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Solutions from Research to Manufacturing

No matter what stage of cell therapy development you are at, our solutions can help you achieve the goal of cell therapy -- commercialization. We offer a large portfolio of solutions as well as quality control solutions for cell culture and modification. Careful selection of raw materials and complete process development are necessary for cell therapy products from research and development to clinical application. Our solutions will help you translate your therapeutic regimens into clinical applications. We extends our solutions to keep up with your steps toward commercialization to satisfy various clinical needs.

1  Cell Isolation and Activation

Gibco™ Dynabeads CD3/CD28 CTS Magnetic Beads

It is used for isolation, activation and amplification of human T-cells in vitro. The first FDA-approved Novartis KymriahTM CAR-T cell therapy to fight B-cell precursor ALL, adopting Thermo Fisher Scientific CTS Dynabeads technology.

* Plasmid Production

Oxoid™ microbial media enjoys a long history and a wide range of varieties. Among which, pancreatic casein peptone (LP0042), phytone peptone (VG0100) and yeast extract (LP0021) can be used in Escherichia coli culturing to achieve enrichment and extraction of plasmids for cell therapy.

 
 

Invitrogen™ CTS DynaMag Magnet Large-Volume Sorting Magnetic Stand

It is used in combination with Dynabeads CD3/CD28 CTS in clinical studies to remove Dynabeads magnetic beads from T-cells after in vitro stimulation/amplification.

Thermo Scientific™ Heraeus Cyrofuge 8 Large-Capacity Floor-standing Centrifuge

The large capacity allows isolation of peripheral blood cells by centrifugation of 24×200ml blood bags at 7144×g, which meets the experimental standards of cell therapy. It features a highly sensitive touch screen that can be operated with gloves on, as well as one-button automated lid opening/closing function and built-in data management function, providing an excellent centrifugation solution for standardized cell therapy laboratories.

Gibco™ CTS™ Rotea™ Counterflow Centrifugation System

Gibco™ CTS™ Rotea™ Counterflow Centrifugation System is a flexible, scalable and closed cell processing system suitable for cell therapy production. It applies the mature counterflow centrifugation method to a wide range of cell processing applications, such as CAR T-cell therapy, stem cell therapy and PBMC isolation. The CTS Rotea system contains a compact multifunctional instrument, a single-use sterile kit, and the intuitive, visualized and customizable program software. Together, they constitute a closed system that provides excellent cell recovery rate, flexible input and output volumes, and efficient processing capabilities. It is ideal for a series of processes in your workflow, including cell isolation, concentration, washing, buffer replacement, and cryopreservation.

 

2  Cell Genetic Modification

Gene Editing

Invitrogen™ TrueCut™ Cas9 Protein

The new generation of Cas9 protein can provide higher gene editing efficiency, and has always been superior in efficiency for targets that are difficult to deal with in immune and primary cells.

Invitrogen™ Neon™ Electroporation Transfection System

The Invitrogen Neon™ Electroporation Transfection System delivers DNAs, RNAs and proteins to a variety of blood cell lines and primary T-cells, achieving a transfection efficiency of 90%.

 
 

Lentiviral Production (Adherence)

Invitrogen™ Lipofectamine™ 3000 Transfection Reagent

The efficient and economical lentiviral production tool for adherent cells enables high viral titer even for large or hard-to-package genes. With the excellent transfection efficiency, it can raise the transfection efficiency of hard-to-transfect cells by 10 times.

Thermo Scientific™ Nunc™ Cell Factory™

It is widely used in large-scale cell culturing and the preparation of bioactive substances, which can effectively save the acclimation and linear amplification time required by large-scale cell culturing, meanwhile minimizing contamination, especially suitable for the preparation of viruses.

 
 

Lentivirus Isolation and Collection

Thermo Scientific™ Sorvall WX+ UltraCentrifuge Series

It enables higher centrifugation yield and safer centrifugation operation with its compact appearance, self-balancing rotor, and a maximum speed of 100,000 rpm, which meets the experimental requirements on lentivirus isolation and collection. The lightweight and durable Fiberlite™ carbon fiber rotor does not need to be used at a reduced speed.

 
 
 

Lentiviral Production (Suspension)

Glibco™ LVmax™ Lentiviral Production System

It is able to obtain a high-titer virus yield greater than 1×108 TU/ml (unconcentrated). The system is serum-free and is the first complete lentivirus suspension production system.

Thermo Scientific™ Single-Use Bioreactor

The 50L single-use bioreactor (SUB) provides a culture volume of 10-50L. It has been verified to be suitable for various cell lines, such as HEK293, CHO, SP20 hybridoma, NS0, PER.C6, Vero, MDCK, etc.

CTS TrypLE™ Select

It is a recombinant protease that complies with the new regulations of the National Center for Drug Evaluation (CDE) for cell therapy product process and has particular advantages in this application:

  • Free of any animal- or human-derived ingredients, with little difference between batches
  • The activity is consistent with that of animal-derived pancreatin
  • Avoid potential risks of viruses and prions
  • The full name of the product is traceable and the drug master file is filed with FDA
 

Thermo Scientific™ Nalgene™ Conical Culture Flask

It is made of lightweight, crack-resistant and transparent PETG, with available options of various sizes of vented or non-vented conical culture flasks, which are flat-bottomed with or without baffle. They are used on the benches or oscillators, achieving consistent performance in the cultivation of various cell types.

Gibco TrypLE™ Select Enzyme

It is a highly purified non-animal recombinant enzyme that can be an alternative for porcine or bovine trypsin for digestion of adherent cells such as HEK293 cells, mesenchymal stem cells and iPSC. It acts mildly on cells and does not require trypsin inhibitors; it can be stored at room temperature and is easy to use.

 
 

3  Cell Amplification and Washing

Cell Culture

Gibco™ CTS™ AIM V™ Medium

It is the first commercial T-cell and dendritic cell proliferation and treatment product with a serum-free formula with defined components, and is produced in strict accordance with cGMP standards. This medium is an FDA Class II medical device. The drug master file has been submitted to the FDA.

Gibco™ CTS™ OpTmizer™ T-cell Expansion Medium

It is a serum-free, xeno-free medium suitable for the growth and expansion of human T lymphocytes, and is produced in strict accordance with cGMP standards. This medium is an FDA Class II medical device. The drug master file has been submitted to the FDA.

Gibco™ CTS™ Immune Cell Serum Replacement (SR)

It is a xeno-free formula with definite components, which can be added to standard basal media as a substitute for human serum. It is produced in strict accordance with cGMP standards. The drug master file has been submitted to the FDA.

 

Gibco™ CTS™ Cytokine and Growth Factor

It is a high-quality growth factor and cytokine used for T-cell, stem cell and dendritic cell applications. The production of CTS cytokines and growth factors meets the requirements of FDA 21 CFR Part 820: Medical Devices Quality System Regulation (QSR). Growth factors are produced in compliance with ISO 12485:2003 Medical Devices - Quality Management System - Requirements for Regulatory Purposes. The drug master file has been submitted to the FDA.

Thermo Scientific™ Forma/Heracell Carbon Dioxide Incubator and Cell Locker™ Chamber

It provides a clean space with contamination prevention and control function through the proven technology of high-temperature dry heat/moist heat sterilization, and has a variety of upgrade combinations, such as built-in shakers and independent space management solutions.

Thermo Scientific™ 1300 Series A2 Biological Safety Cabinet

Strict contamination control; unique Smartflow™ airflow system; SmartClean patented front window cleaning position design; comfortable armrest and low noise.

 

Single-use Equipment

Finesse SmartBag/Smart Rocker

SmartBags can accommodate the cultures at 10-50L; SmartRocker can provide great wave angles to suspend high-density culture cells.

 
 
 

4  Quality Control and Release

Applied Biosystems™ 7500 Fast Dx Real-Time PCR Instrument

It is based on semiconductor refrigeration technology (Peltier thermoelectric module technology) to deliver the performance required for high-quality results in the form of 96-well plates. It can identify 5,000 to 10,000 genomic equivalents (2 times copy number difference) with a confidence level of 99.7%.

Applied Biosystems™ MycoSEQ™ Mycoplasma Detection Kit

High sensitivity and various detection types, meeting the requirements of USP, EP, JP and ICH.

Applied Biosystems™ 3500 Series Genetic Analyzer

It performs fragment analysis and Sanger sequencing, including but not limited to STR/microsatellite analysis, loss of heterozygosity, SNP validation and screening, and ab initio sequencing and resequencing (mutant spectrum analysis). It provides dual-mode functions and is more flexible; it is equipped with powerful and integrated data acquisition and preliminary analysis software, which allows real-time data quality evaluation; it is simple to set up, operate and maintain.

 

Invitrogen™ Countless™ II FL Automated Cell Counter

The benchtop cytometer is equipped with advanced optical components and image analysis software for automated focusing and rapid counting of suspended cells. It is suitable for cells of size 7-60 μm to be counted with this method.

Thermo Scientific™ CellInsight CX7 High-Content Screening (HCS) System

High-resolution automated cell quantification imaging and analysis; used for high-throughput screening of effective T-cell chimeras; efficiently evaluating the killing efficiency of CAR T-cells (the percentage of targeted tumor cells killed), and automatically exporting the analytical data.

Invitrogen™ Attune™ NxT Flow Cytometer

It is a brand-new benchtop flow cytometer with innovative acoustic focusing technology, flexible configuration, up to 4-laser and 14-color system, which is fast and unblocked.

 

Thermo Scientific™ Multiskan ET Kinetic Endotoxin Detector

It adopts a patented optical system and single-channel detection, with a detection wavelength range of 340-850nm, which meets the detection requirements of a variety of limulus/tachypleus amebocyte lysate reagents, and can perform kinetic chromogenic and kinetic turbidimetric detection to ensure high accuracy of readings.

Thermo Scientific™ Varioskan LUX Multimode Microplate Reader

It integrates multiple optical detection technologies, including light absorption, fluorescence, chemiluminescence, time-resolved fluorescence and Alpha, which can meet the detection needs of multiple quality control indicators such as cell viability, toxicity, proliferation, and reporter gene expression.

Thermo Scientific™ Q Exactive Ultra High-Resolution Liquid Chromatography-Mass Spectrometry (LC-MS)

It identifies, confirms and quantifies non-target or target compounds and proteins in a quick and reliable way, and is especially suitable for cell therapy mechanism research, new target discovery and verification, quality control research, and drug packaging material detection.

 

Thermo Scientific™ Vanquish Ultra High-Performance Liquid Chromatography (HPLC)

Built with biologically inert materials, it is more suitable for the isolation and detection of biological sample analysis; with better retention time stability, excellent sensitivity and isolation efficiency, it is designed to meet strict engineering standards, and is adaptable to various detectors, which is especially suitable for cell therapy quality control research and detection of drug packaging materials and dextran 40.

Thermo Scientific™ VersaTREK Automated Microbial Culture System

The automated microbial culture system is approved by FDA and CFDA. With its unique barometric pressure sensor technology and VorTREXing™ vortex culture technology, positive results can be obtained more quickly and sensitively, helping to reduce the risk of microbial contamination.

 
 

Experimental Preparation

Thermo Scientific™ GENEPURE Ultrapure Water Meter

Thermo Scientific™ 88880005 Hot Plate

Thermo Scientific™ 88880018 Vortex Oscillator

 

Thermo Scientific™ Finnpipette F1 Single Channel (Multichannel) Pipette

Thermo Scientific™ S1 Pipette Filler

Thermo Scientific™ PLR-3864°C Laboratory Refrigerator

 

5  Storage and Cold Chain Transportation

Thermo Scientific™ Cyromed Controlled-Rate Freezer

It offers high flexibility of controlled-rate freezing where multiple freezing curves can be customized according to specific solutions.

Thermo Scientific™ CyroExtra40 High-Efficiency Gas Phase Liquid Nitrogen Tank/CyroPlus Liquid Nitrogen Storage Tank

Large storage capacity: 20,000 to 90,000 cryopreservation tubes; gas phase storage, preventing tube bursts, with extremely low probability of contamination; good thermal insulation performance: -190°C ±5°C; liquid nitrogen consumption is equivalent to that of a small liquid nitrogen tank.

Thermo Scientific™ Forma Ultra-Low Temperature Freezer

50% energy saving; quiet, 20 times quieter than traditional Ultra-Low Temperature freezers; long warranty period, 5-year warranty for the whole machine; it is environmentally friendly and uses fluorine-free hydrocarbon refrigerants (ethane and propane), which meets K6 standards.

 

Thermo Scientific™ Arctic Express Sample Transport Tank

The unique material absorbs liquid nitrogen and ensures the transportation of samples at low temperatures below -160°C without any risk of liquid nitrogen leakage. The cryopreservation time is 7-21 days. A dedicated IATA certified high-risk sample transport tank is available.

 
 
 

Thermo Fisher Scientific T-cell Immune Repertoire Solutions

The strategy to realize precision medicine in oncology by influencing an individual’s immune system has always been a common research goal of numerous scientists for many years. However, the complex oncology-immune interactions require multidimensional solutions, so as to achieve well-designed translational studies and analysis of results. Genomics solutions based on the next generation sequencing (NGS) can be a promising powerful tool for driving major discoveries in translational and clinical research.

Using the Ion Torrent long-segment NGS platform to exert the power of immune repertoire research

By analyzing the immune repertoire to obtain the diversity of T-cell receptor (TCR) gene recombination, it can help you make significant advances in immunooncology research. Ion AmpliSeq™ Immune Repertoire Assay Plus and TCR provide a fast, long-segment long-read NGS tool for complex cellular immunology research. This integrated solution includes:

 

Identification of immune response biomarkers

- Accurately measure the diversity and clonal amplification of the T-cell immune repertoire, identify antigen-specific T-cells, and promote translational research.

 

Optimizing the function and production of potential therapeutic T-cells

- Identify the TCR chain sequence, and optimize the production of genetically engineered T-cells.

 

Investigating the markers of immune-mediated adverse events (IMAEs)

- All three complementarity determining regions (CDR1, CDR2, and CDR3) are analyzed for allele-specific polymorphisms in these regions, which may be associated with autoimmune diseases and IMAEs.

 

Based on the reliable and widely referenced Ion AmpliSeq™ technology, our well-designed NGS solution can significantly improve your turnaround time, that is, it only takes 48 hours from samples to results (Figure 1). Ion AmpliSeq Immune Repertoire Assay Plus and TCR can read up to 400 bp amplicon length for complete analysis of CDR1, CDR2, and CDR3 (Figure 2). The mRNA-based sequencing is highly accurate, and the primer bias for PCR introduction is extremely low.

V-genes

Data security

- You can have full control over your data (no service mode and additional fees) and ensure the transparency of analysis. Your TCR sequence is always reserved for you.

 

Accuracy

- With RNA as a starting point, you do not have to worry about recombination of TCR chain genes, and you could benefit from the low replacement error rate of the Ion S5 system.

 

Low sample demand

- Based on your sample situation and requirements, the AmpliSeq library can be constructed just with a sample volume of 10ng-1μg.

 
 

Stem cell therapy

Stem cell is a kind of cell that are not fully differentiated and have not yet matured. They have the potential of self-replication and differentiation and can differentiate into various types of multifunctional cells in the body under certain conditions. Stem cell therapy has become a key research field at international medical frontier, bringing unlimited potential to diseases that cannot be cured by current medical technology. For example, in the field of organ transplantation, stem cells can be differentiated into different types of somatic cells such as hepatic cells, kidney cells, lung cells and heart cells, and finally construct corresponding human organs by means of tissue engineering.

Mesenchymal stem cells

Gibco Cells

StemPro™ BM Mesenchymal Stem Cells *

Cell Customization and Service

Thermo Scientific Cell Culture Plastics

Nunc™ Cell Culture Dishes

Nunc™ Cell FactoryTM System

* Research use only

Gibco Amplification Culture System

CTS StemPro MSC SFM

StemPro MSC SFM Xenofree

CTS CELLstart Substrate

CTS™ GlutaMAX™-I Supplement

CTS TrypLE Select

Custom Media and Services

Gibco Differentiation Medium

StemPro Osteogenesis Differentiation Kit

StemPro Chondrogenesis Differentiation Kit

StemPro Adipogenesis Differentiation Kit

Gibco Growth Factor

CTS TGF-β1

CTS FGF-Basic

Thermo Scientific Single-use Technology

Bioreactor/Lining

Transfer Components

Cell Culture and Biological Production System

Nunc™ Cell Culture Dishes

Invitrogen Gene Modification

MessengerMAXTM Transfection Reagent

LipofectamineTM 3000 Transfection Reagent

LipofectamineTM 2000 CD Transfection Reagent

GeneArt Elements Services

CaptureSelect™ Affinity Matrix

CRISPR-Cas9 Products and Services

Designer TALEN Products and Services

Invitrogen Electroporation Device

Neon Electroporation Transfection System

Thermo Scientific Plastics and Imaging Petri Dishes

Nunc™ Cell FactoryTM system

Nunc™ Plate

Gibco Washing

CTS DPBS

Gibco Cryopreservation Medium

CTS Synth-a-Freeze Medium

Cryopreservation

Nalgene 和Nunc cryotubes

Biobank Services

Thermo Scientific Arctic Express

Sample Transport Tank

Thermo Scientific Forma Ultra-Low Temperature Freezer

Batch release testing

Safety

Identification

Efficacy

Purity

Process characterization analysis

Functional analysis

Cell analysis

Protein analysis

Genetic analysis

 

Mesenchymal stem cell therapy

Gibco™ CTS™ StemPro™ MSC Substrate

Gibco™ CTS™ StemPro™ MSC Serum-free Medium (SFM) - a serum-free medium specially designed for the growth and amplification of human mesenchymal stem cells (MSCs) and human adipose derived stem cells (ADSCs).

  • Excellent consistency in the growth and proliferation of human MSC is achieved compared to the classic serum supplement medium (DMEM + 10% FBS)
  • Using CTS StemPro MSC SFM, human MSC can be amplified for more than 5 generations while its three-line mesodermal differentiation potential is retained
  • Human MSCs cultured in serum-supplemented medium can be directly converted into CTS StemPro MSC SFM with little adaptation

Gibco™ CTS™ CELLstart Substrate

As the first cell culture substrate with fully-defined xeno-free components, it enables adhesion and serum-free amplification of human MSCs, providing an excellent substrate for applications requiring more similar physiological conditions in vivo.

  • It contains only components of human origin (xeno-free) and has stable interbatch performance
  • It helps to maintain the pluripotency, morphology and three-line mesodermal differentiation potential of human MSCs
  • Full traceability of products; reliable production conditions; drug master file filing

Gibco™ StemPro™ Differentiation Kit

It is used for the standardized differentiation of cultured human mesenchymal stem cells (MSCs), supporting the reliable induction of MSCs into chondroblasts, osteoblasts, and adipocytes in serum-free conditions.

  • As a complementary product to CTS StemPro MSC SFM, StemPro MSC SFM XenoFree, and MesenPRO RS Medium as well as MSC-proven FBS Cell Amplification System
  • Each batch has been verified
  • Also can support the differentiation application of rat and mouse MSCs
 

Pluripotent stem cells

Gibco Isolation

(T-cell) CTS Dynabeads CD3/CD28 Beads

Gibco Medium

(T-cell) OpTmizer Medium

(PBMC/CD34 cell)

StemPro™-34 SFM

(Fibroblast) CTS™ KnockOut™

SR Xenofree

Gibco Decomposition Reagent

CTS™ TrypLE™ Select Enzyme

Invitrogen Reprogramming Kit

CytoTune™-iPS 2.0 Sendai Reprogramming Kit

Invitrogen Transfection Reagent

(Fibroblast) Lipofectamine™ 3000 Transfection Reagent

Invitrogen Electroporation Device

(T-cell) Neon Electroporation Transfection System

Gibco cryopreservation

CTS Synth-a-Freeze Medium

PSC Cryopreservation kit

RevitaCell™ Supplement

Essential 8 / CTS VTN

rh-Laminin 521

Gibco Proliferation Medium System

CTS™KnockOut™ SR, XenoFree

CTS™ KnockOut™ DMEM/F-12

CTS KnockOut SR

CTS™ CELLstart™ Substrate

Essential 8TM Medium/CTS VTN

EDTA / Versene

RevitaCell™ Supplement

Essential 8 / CTS VTN

rh-Laminin 521

Medium Customization and Services

Invitrogen Gene Editing

CRISPR-Cas9 Products and Services

DesignerTALEN Products and Services

Liposome Transfection Reagent

Lipofectamine™ MessengerMAX™

Transfection Reagent

Thermo Scientific Single-use Technology

Bioprocess Containers (BPCs)

Transfer Components

Electrostatic Discharge (ESD) Bags

Wave Culture Bags

Nunc

Gibco Differentiation Reagent

PSC Cardiomyocyte Differentiation Kit

PSC Dopaminergic Neuron Differentiation Kit

PSC Definitive Endoderm Induction Kit

CTS™ B-27 Supplement, XenoFree

CTS™ N-2 Supplement

CTS KnockOut DMEM / F-12

CTS™ Neurobasal™ Medium

CTS™ Neurobasal™-A Medium

CTS™ Neurobasal™-A Medium

CultureOne™ Supplement

Gibco Growth Factor

CTS™ TGF-β1

CTS™ Stem Cell Factor (SCF)

CTS™ FLT 3 Ligand

CTS™ FGF Basic Full Length

Gibco Washing

CTS DPBS

Gibco Cryopreservation Medium

CTS Synth-a-Freeze Medium

Cryopreservation and Logistics

Nalgene™ and Nunc™ Cryogenic Tubes

Biobank Services

 

Pluripotent stem cell therapy

Gibco™ Essential 8™ Series Medium

Gibco Essential 8 Series Medium is a serum-free, xeno-free, and feeder-free medium developed on the basis of James Thomas. It contains only 8 essential components necessary for maintaining the growth and amplification of pluripotent stem cells, supports iPSC culture for more than 50 generations without any abnormal signs of cell karyotype, and can maintain the ability of iPSCs to differentiate into all three embryonic lineages.

  • Stable - Xeno-free components and in compliance with cGMP requirements
  • Consistent - Smaller difference between batches compared to the existing feeder-free medium
  • Flexible - This series also provides Essential 6 for embryoid body formation and differentiation applications, and provides the Essential 8 Flex with flexible feeding methods and the CTS Essential 8 medium which is well suited for stem cell transformation applications and is completely human- and animal-origin free (AOF)

Gibco™ CTS™ Vitronectin (VTN-N) Recombinant Human Protein

It provides a definitive surface for feeder-free cell culture of PSCs.

  • Reduces animal-origin, variability and risk of contamination in PSC cultures
  • Provides an excellent environment for feeder-free pluripotent stem cell culture, as the VTN-N variant has been shown to be better than wild-type vitronectin in supporting human PSC attachment and survival
 

Hematopoietic stem cells

Gibco Isolation

Dynabeads CD34 Positive Isolation Kit

DynaMag Magnetic Stand

Thermo Scientific Cell Culture Plastics

Nunc™ Cell Culture Dishes

Gibco Expansion Medium System

StemPro-34 SFM

Custom Media and Services

CTS™GlutaMAX™-I Supplement

Gibco Growth Factor

CTS IL-2, IL-3, CTS IL-4, IL-5, CTS IL-6, CTS IL-7, CTS GM-CSF, CTS SCF, CTS FLT3 ligand, TPO, M-CSF

Thermo Scientific Single-use Technology

Bioreactor/Lining

Transfer Components

Cell Culture and Biological Production System

Nunc™ Cell Culture Dishes

Gibco Washing

CTS DPBS

Gibco Cryopreservation Medium

CTS Synth-a-Freeze Medium

Cryopreservation

Nalgene 和Nunc cryotubes

Biobank Services

Batch release testing

Safety

Identification

Efficacy

Purity

Process characterization analysis

Functional analysis

Cell analysis

Protein analysis

Genetic analysis

 

Hematopoietic stem cell therapy

StemPro™-34 Serum-free Medium (SFM)

The serum-free medium is specially designed for the culture of human hematopoietic stem cells (e.g., CD34+), which is suitable for the culture and subsequent applications of HSC isolated from human bone marrow, peripheral blood or neonatal umbilical cord blood. Compared with the classical serum-attached medium (IMDM + FBS and cytokines), the medium produces better cell amplification effect. The medium contains no cytokines or growth factors, and the components and flexible combination of variables can be adjusted according to your research needs.

Dynabeads™ CD34 Positive Isolation Kit

It is used to isolate a high purity and yield of human CD34 + progenitor stem cells.

Human CD34 + progenitor stem cells can be isolated directly from whole or umbilical cord blood or bone marrow using the bead release method, and the isolated CD34+ cells can be used for any application (i.e., they can differentiate into dendritic cells or natural killer cells).

 

Platform for Science

Digital sample tracking solutions for cell therapy

“Digital solutions have become a global trend, and we have been actively promoting the development of digital solutions in China. Thermo Fisher Scientific has always been committed to the development strategy of ‘in China, for China’. We look forward to leveraging our expertise in cell therapy and digital solutions to improve industry standards, accelerate the development of cell therapy in China, and provide affordable therapeutic regimens for Chinese patients.”

—— Tony Acciarito, President of Greater China, Thermo Fisher Scientific

Thermo Fisher Scientific digital solutionsProduct features
Sample location trackingSample temperature trackingData storage and audit trailData analysis and report generationProcess analysis managementR&D process optimizationProduction batch management (including production execution system for materials, personnel, equipment, documents, etc.)Equipment automation (data collection and central control)
SmartTracker    
SmartLab  
(Tracking the production process only)

(Tracking the production process only)
  
SmartFactory  
(Tracking the production process only)

(Tracking the production process only)
 

Important value of cloud-based Platform for Science

  • Storage of all data in a single platform architecture helps simplify analysis and provides a single source of facts
  • Functions can be easily added at any time through applications, solution sets, and configurations, without the need to write custom code
  • Supporting the use of industry-leading Core OData API to extend the platform to integrate advanced equipment

Platform for Science suitable for scientific data capture, management and analysis

Implemented Platform Methods

The Core layered solution stack shows how applications and products running on the same underlying code base, the Platform for Science, work together. All modifications to the Core solution are completed through configuration, without writing custom code, and are immediately available on the entire platform or through the Core OData API.
Application
The solution focuses on providing modular applications. Applications are composable and the designs are reusable, thus users can rearrange the applications to suit the specific requirements of the workflow.
Product
All the traditional data management products (LIMS, ELN and SDMS) you know about are now integrated into one platform, and products that require collaboration and integration between software systems are integrated.
Platform
The Platform for Science is a flexible “Platform as a Service” (PaaS), which is the foundation of all software products and applications. Solutions and configurations can be added quickly, meanwhile effective communication between products on the entire platform are supported.
 

Accelerating clinical trials - ensuring the quality of clinical drugs is our core value

Understand that patients are waiting for the clinical trial drugs provided by us, especially biologics that are sensitive to transportation time and temperature


A Thermo Fisher Scientific Brand
 

Internationally verified professional logistics services, including

Dedicated to the shipment of time-sensitive clinical trial drugs and biologics for customers, including cold chain solutions, global SOP standards compliance, transportation time shortening, and sample tracking. The scope of application covers research and development of drugs, Phase I to Phase III clinical trials, and commercialization (DTP-DTR-Ph IV), providing accurate logistics information for APIs, clinical trial materials, research samples and vaccines, biosimilars and cell therapies.

Additional services

NFO, charter services, import and export license management and link establishment, cold chain supply and management

Service commitment

Follow global SOPs, global GxP network, round-the-clock freight services, internal audit, and global enterprise-level quality control management committee

 

Fisher clinical trial services are designed to support customers from early stage and later stage trials to commercialization. We will provide full-process services for clinical trials, from clinical production, label design and packaging, storage and supply chain to reverse logistics and destruction. Meanwhile, we also provide auxiliary equipment management and comparator sourcing, biobank storage, total transportation management, and clinical supply optimization services for customers requiring supply chain management or other requirements planning.

Cell quality control

Cell products are ultimately used in the human body, therefore specific quality standards need to be established for quality control. Specifically, the whole process of donor screening, tissue grading, cell isolation, culture, cryopreservation, resuscitation, release, transportation and use requires quality control to ensure the stability, effectiveness and safety of the product.

According to the Points of Consideration for the Application of Clinical Trial Pharmaceutical Research and Application Materials for Cell Therapy Products recently published by the CDE, the applicant is requested to pay special attention to the following points of consideration for pharmaceutical research and application materials on the basis of carrying out relevant research in accordance with the technical guidelines. Among which, quality research (plasmids, viruses, and CAR T-cells) focuses on safety-related projects and conducts risk assessment, especially quality standards for plasmids, viruses, and CAR-T products.

 Determination itemsDetermination methodsThermo Fisher Scientific ’s Equipment or Kits
Plasmid QCpH valueDetermination of pH meterVERSA STAR ProTM Benchtop pH Meter and patented ROSS pH electrodes
Plasmid contentUltraviolet spectrometryNanoDrop™ 3300 Fluorospectrometer
260/280 purityMultiskan Sky Nucleic Acid Protein Analyzer
 Qubit 4 Fluorometer + Reagents
Plasmid DNA homogeneityAgarose electrophoresisE-Gel Precast Agarose Gel Electrophoresis System + Reagents
Genetic sequencingSequencing3500 Dx/SeqStudio Genetic Analyzer
SterilityMicrobial Culture SystemVersaTREK Automated Microbial Culture System
No endotoxinPhotometryMultiskan Microplate Reader + Reagents
Host RNA residueqPCRPowerUp™ SYBR™ Green
TaqMan™ Fast Advanced Master Mix
7500 DX Fast Real-Time PCR System
QuantStudio™ Dx Real-Time PCR system
Host gene residueqPCRresDNASEQ® E. coli Residual DNA Quantitation System and resDNASEQ® Human Residual DNA Quantitation Kit
7500 DX Fast Real-Time PCR System
QuantStudio™ Dx Real-Time PCR system
DNA probe hybridizationE-Gel Precast Agarose Gel Electrophoresis System + Reagents
Host protein residueELISAMultiskan Sky Nucleic Acid Protein Analyzer
 BCA Kit
 Determination itemsDetermination methodsThermo Fisher Scientific ’s Equipment or Kits
Viral vector QCpH valueDetermination of pH meterVERSA STAR ProTM Benchtop pH Meter and patented ROSS pH electrodes
Osmotic pressure molar concentrationDetermination by the molar concentration meterAdvance 3250 Single-Sample Osmometer
CAR gene identificationqPCRApplied Biosystems™ 3500 Series Genetic Analyzer
Virus titerPhysicochemical determination - qPCR7500 DX Fast Real-Time PCR System
Biological function determination - ELISAVarioskan LUX
DNA residueqPCRresDNASEQ® E. coli Residual DNA Quantitation System and resDNASEQ® Human Residual DNA Quantitation Kit
7500 DX Fast Real-Time PCR System
QuantStudio™ Dx Real-Time PCR System
DNA probe hybridizationE-Gel Precast Agarose Gel Electrophoresis System + Reagents
Residual host DNA transfer (SV40, E1A, etc.)qPCR7500 DX Fast Real-Time PCR System
QuantStudio™ Dx Real-Time PCR System
Conventional PCRProFlex™ Thermal Cycler
E-Gel Precast Agarose Gel Electrophoresis System + Reagents
Protein residueELISAMultiskan Sky Nucleic Acid Protein Analyzer
BCA Kit
BSA residue Multiskan Sky Nucleic Acid Protein Analyzer
BCA Kit
Nuclease residue Multiskan Sky Nucleic Acid Protein Analyzer
BCA Kit
RNaseAlert® QC System v2
DNaseAlert™ QC System
RCR/RCLqPCR7500 DX Fast Real-Time PCR System
QuantStudio™ Dx Real-Time PCR System
SterilityMicrobial Culture SystemSterile Microbial Culture System VersaTREK
Automated Microbial Culture System
No endotoxinPhotometryMultiskan Microplate Reader + Reagents
MycoplasmaqPCRMycoSEQ Mycoplasma Detection Kit
7500 DX Fast Real-Time PCR System
QuantStudio™ Dx Real-Time PCR System
DNA stainingDNA Staining Evos XL
Exogenous virus detectionCell morphology observation and hemadsorption testInvitrogen™ EVOS™ microscope for exogenous virus detection cell morphology observation and hemadsorption test
 Determination itemsDetermination methodsThermo Fisher Scientific’s Equipment or Kits
CAR T-cell product QCpH valuepH meterpH Meter, VERSA STAR Protm Benchtop pH Meter and patented ROSS pH electrodes
Osmotic pressureOsmometerAdvanced Model 3250 Single-Sample Osmometer
Viable cell densityFlow cytometer + dyeAttune NxT
Dead/Live Dye
Cell viabilityFlow cytometer + dyeAttune NxT
Sytox Series Dyes or PI, etc.
Proportion of CD3+T-cellsFlow cytometer + antibodyAttune NxT
Human CD3 Antibody
CD3+CRT+ cellsFlow cytometer + antibodyAttune NxT
Human CD3 Antibody and Secondary Antibody
Proportion of unrelated cellsFlow cytometer + antibodyAttune NxT
Cell typingFlow cytometer + antibodyAttune NxT
Different Flow Antibody
BioactivityDyeDye Vybrant™ MTT Cell Proliferation Assay Kit + MTT
MTT stainingVarioskan LUX Multimode Microplate Reader
MTT stainingThermo Scientific Multiskan SkyHigh Microplate Spectrophotometer
Cell countCell counterInvitrogen™ II FL Automated Cell Counter
RCR/RCLqPCR instrument7500 DX Fast Real-Time PCR System
Vector copy number QuantStudio™ Dx Real-Time PCR System
SterilityMicrobial rapid culture systemVersaTREK Automated Microbial Culture System
Identification of microbial strainsRapID Rapid Identification Strip
Identification of microbial strainsARIS 2X Automated Microbial Identification and Drug Sensitivity Analysis System
No endotoxinMicroplate reader + limulus/tachypleus amebocyte lysate reagentMultiskan ET Reader + Reagents
MycoplasmaMycoplasma Detection Kit for qPCR instrumentsMycoSEQ Mycoplasma Detection Kit
7500 DX Fast Real-Time PCR System
QuantStudio™ Dx Real-Time PCR System
Magnetic bead residueOptical microscopeInvitrogen™ EVOS™ Microscope

Tools for in-process quality control and interbatch testing

Invitrogen™ Attune™ NxT Flow Cytometer

A tool for in-process and interbatch testing - a true benchtop flow cytometer that blends precision with performance, with up to 4 lasers and 16 test parameters.

  • Anti-blocking design, acoustic focusing cytometry technology and high-quality fluid technology help prevent the loss of valuable samples and enable the analysis of hard-to-analyze samples such as tumors
  • 10 times faster than other flow cytometers and can provide superior data fidelity
  • The plate autosampler can achieve true automation on conventional and 96- or 384-well deep well plates

 
Functions of Invitrogen™ Attune™ NxT Flow Cytometer
Cell viabilitySelect Invitrogen™ viability staining analysis
Plasmid Content

Invitrogen™ Click-iT™ EdU detection provides:

  • Quantification of newly synthesized DNA
  • No DNA degeneration was detected
  • Compatible with sensitive R-PE tandems and fluorescent proteins
  • Replace cumbersome BrdU detection
Detection of Cell Populations

Cells are permanently labeled with fluorescent staining to track generation or division without affecting morphology or physiology. Invitrogen™ CellTrace™ Cell Proliferation Kit provides:

  • Cell tracking in vitro or in vivo
  • Bright unimodal staining
  • Long-term signal stability

Applied Biosystems™ MycoSEQ™ Mycoplasma Detection Kit

It can achieve highly sensitive, specific and overall detection of more than 90 mycoplasma species. These kits are specifically designed for routine screening and detection of mycoplasma and closely related species, such as Acholeplasma laidlawii and Spiroplasma citri, and are in compliance with European Pharmacopoeia guidelines.

  • Highly optimized sample preparation; test results are verified during the same day (results are usually obtained within < 5 hours)
  • Widely used and validated by biopharmaceutical users
  • App support is included to guide you through the validation process
  • The detection sensitivity is proven to be < 10 CFU/mL

 

Environmental Monitoring

1. Monitoring of planktonic bacteria

Thermo Scientific Air Sampler

  • Flexibility: The sampler accepts either a native built-in program or a user-defined program, providing flexibility in sampling volume, delayed start, multi-functional running and interval sampling.
  • Acquisition efficiency: The validation work carried out by an independent laboratory in accordance with BS EN ISO 14698-1:2003 has shown that the air sampler has achieved 100% physical acquisition efficiency for particles within the range of 0.8 to 19.0 microns.
  • Data processing: Sampling records can be stored and data can be downloaded to a computer for reporting and trend analysis.
  • Calibration services available
 

2. Plates for monitoring the planktonic bacteria and settling bacteria

  • Prepared with high-quality Oxoid dry powder medium: Tryptone soya agar (TSA) medium, sabouraud dextrose agar (SDA) medium or other media are available
  • Three layers of sterile packaging products; does not require 100% preculture

3.1 Surface Monitoring Contact Plate

  • It can be used to sample and cultivate microorganisms on the surface of equipment, floors, walls, countertops, human hands, clothes, etc.
  • Three layers of sterile packaging products, does not require 100% preculture
 

3.2 Contact Plate Controller

  • Standardized microbial surface control sampling process
  • Suitable for contact plates of different specifications; able to perform up to 10 seconds of standardized sampling with a weight of 500g, with acoustic and visual cues
 
 

Final Product Low-temperature Microbial Culture

RI Series Low-Temperature Incubator

  • Temperature range of 4-60°C, temperature uniformity ≤ ±0.8°C (@20°C), temperature deviation ≤ ±0.3°C (@20°C), precise temperature control and repeatable experimental results
  • Reliable and stable compressor refrigeration technology, automated defrosting, which is suitable for long-term applications below ambient temperature
  • Convenient sample viewing through the observation window on the door; the standard access port and timing function on the right side is a great convenience to users

IMP Series Low-Temperature Incubator

  • Provide a temperature range of 5-70°C, with benchtop and floor-standing models available, temperature uniformity of ±0.3°C (@25°C), and temperature stability of ±0.1°C, ensuring good experimental reproducibility
  • Peltier semiconductor refrigeration technology saves more than 80% energy than conventional compressor models, ensuring temperature uniformity and stability, with extremely low vibration, and optimized temperature distribution for the inner cavity fan
  • DIN12880 Class2.0 adjustable over-temperature protection function, and the over-temperature automated heating cut-off is an extremely high guarantee for safe applications
  • Intuitive programming function; up to 10 stored programs; daily/weekly/real-time precise timing; extremely easy operation
 

Consultancy on the construction of new laboratories and plants for the preparation of CAR T-cells

From laboratory research, pilot plant to mass production, Thermo Fisher Scientific helps you build your laboratory starting from site planning and process setting with reference to GLP and GMP regulations, and maintain consistency of processes and results during the scaling up process.

1  Cell Isolation and Activation

Gibco™ Dynabeads CD3/CD28 CTS Magnetic Beads

It is used for isolation, activation and amplification of human T-cells in vitro. The first FDA-approved Novartis KymriahTM CAR-T cell therapy to fight B-cell precursor ALL, adopting Thermo Fisher Scientific CTS Dynabeads technology.

* Plasmid Production

Oxoid™ microbial media enjoys a long history and a wide range of varieties. Among which, pancreatic casein peptone (LP0042), phytone peptone (VG0100) and yeast extract (LP0021) can be used in Escherichia coli culturing to achieve enrichment and extraction of plasmids for cell therapy.

 
 

Invitrogen™ CTS DynaMag Magnet Large-Volume Sorting Magnetic Stand

It is used in combination with Dynabeads CD3/CD28 CTS in clinical studies to remove Dynabeads magnetic beads from T-cells after in vitro stimulation/amplification.

Thermo Scientific™ Heraeus Cyrofuge 8 Large-Capacity Floor-standing Centrifuge

The large capacity allows isolation of peripheral blood cells by centrifugation of 24×200ml blood bags at 7144×g, which meets the experimental standards of cell therapy. It features a highly sensitive touch screen that can be operated with gloves on, as well as one-button automated lid opening/closing function and built-in data management function, providing an excellent centrifugation solution for standardized cell therapy laboratories.

Gibco™ CTS™ Rotea™ Counterflow Centrifugation System

Gibco™ CTS™ Rotea™ Counterflow Centrifugation System is a flexible, scalable and closed cell processing system suitable for cell therapy production. It applies the mature counterflow centrifugation method to a wide range of cell processing applications, such as CAR T-cell therapy, stem cell therapy and PBMC isolation. The CTS Rotea system contains a compact multifunctional instrument, a single-use sterile kit, and the intuitive, visualized and customizable program software. Together, they constitute a closed system that provides excellent cell recovery rate, flexible input and output volumes, and efficient processing capabilities. It is ideal for a series of processes in your workflow, including cell isolation, concentration, washing, buffer replacement, and cryopreservation.

 

2  Cell Genetic Modification

Gene Editing

Invitrogen™ TrueCut™ Cas9 Protein

The new generation of Cas9 protein can provide higher gene editing efficiency, and has always been superior in efficiency for targets that are difficult to deal with in immune and primary cells.

Invitrogen™ Neon™ Electroporation Transfection System

The Invitrogen Neon™ Electroporation Transfection System delivers DNAs, RNAs and proteins to a variety of blood cell lines and primary T-cells, achieving a transfection efficiency of 90%.

 
 

Lentiviral Production (Adherence)

Invitrogen™ Lipofectamine™ 3000 Transfection Reagent

The efficient and economical lentiviral production tool for adherent cells enables high viral titer even for large or hard-to-package genes. With the excellent transfection efficiency, it can raise the transfection efficiency of hard-to-transfect cells by 10 times.

Thermo Scientific™ Nunc™ Cell Factory™

It is widely used in large-scale cell culturing and the preparation of bioactive substances, which can effectively save the acclimation and linear amplification time required by large-scale cell culturing, meanwhile minimizing contamination, especially suitable for the preparation of viruses.

 
 

Lentivirus Isolation and Collection

Thermo Scientific™ Sorvall WX+ UltraCentrifuge Series

It enables higher centrifugation yield and safer centrifugation operation with its compact appearance, self-balancing rotor, and a maximum speed of 100,000 rpm, which meets the experimental requirements on lentivirus isolation and collection. The lightweight and durable Fiberlite™ carbon fiber rotor does not need to be used at a reduced speed.

 
 
 

Lentiviral Production (Suspension)

Glibco™ LVmax™ Lentiviral Production System

It is able to obtain a high-titer virus yield greater than 1×108 TU/ml (unconcentrated). The system is serum-free and is the first complete lentivirus suspension production system.

Thermo Scientific™ Single-Use Bioreactor

The 50L single-use bioreactor (SUB) provides a culture volume of 10-50L. It has been verified to be suitable for various cell lines, such as HEK293, CHO, SP20 hybridoma, NS0, PER.C6, Vero, MDCK, etc.

CTS TrypLE™ Select

It is a recombinant protease that complies with the new regulations of the National Center for Drug Evaluation (CDE) for cell therapy product process and has particular advantages in this application:

  • Free of any animal- or human-derived ingredients, with little difference between batches
  • The activity is consistent with that of animal-derived pancreatin
  • Avoid potential risks of viruses and prions
  • The full name of the product is traceable and the drug master file is filed with FDA
 

Thermo Scientific™ Nalgene™ Conical Culture Flask

It is made of lightweight, crack-resistant and transparent PETG, with available options of various sizes of vented or non-vented conical culture flasks, which are flat-bottomed with or without baffle. They are used on the benches or oscillators, achieving consistent performance in the cultivation of various cell types.

Gibco TrypLE™ Select Enzyme

It is a highly purified non-animal recombinant enzyme that can be an alternative for porcine or bovine trypsin for digestion of adherent cells such as HEK293 cells, mesenchymal stem cells and iPSC. It acts mildly on cells and does not require trypsin inhibitors; it can be stored at room temperature and is easy to use.

 
 

3  Cell Amplification and Washing

Cell Culture

Gibco™ CTS™ AIM V™ Medium

It is the first commercial T-cell and dendritic cell proliferation and treatment product with a serum-free formula with defined components, and is produced in strict accordance with cGMP standards. This medium is an FDA Class II medical device. The drug master file has been submitted to the FDA.

Gibco™ CTS™ OpTmizer™ T-cell Expansion Medium

It is a serum-free, xeno-free medium suitable for the growth and expansion of human T lymphocytes, and is produced in strict accordance with cGMP standards. This medium is an FDA Class II medical device. The drug master file has been submitted to the FDA.

Gibco™ CTS™ Immune Cell Serum Replacement (SR)

It is a xeno-free formula with definite components, which can be added to standard basal media as a substitute for human serum. It is produced in strict accordance with cGMP standards. The drug master file has been submitted to the FDA.

 

Gibco™ CTS™ Cytokine and Growth Factor

It is a high-quality growth factor and cytokine used for T-cell, stem cell and dendritic cell applications. The production of CTS cytokines and growth factors meets the requirements of FDA 21 CFR Part 820: Medical Devices Quality System Regulation (QSR). Growth factors are produced in compliance with ISO 12485:2003 Medical Devices - Quality Management System - Requirements for Regulatory Purposes. The drug master file has been submitted to the FDA.

Thermo Scientific™ Forma/Heracell Carbon Dioxide Incubator and Cell Locker™ Chamber

It provides a clean space with contamination prevention and control function through the proven technology of high-temperature dry heat/moist heat sterilization, and has a variety of upgrade combinations, such as built-in shakers and independent space management solutions.

Thermo Scientific™ 1300 Series A2 Biological Safety Cabinet

Strict contamination control; unique Smartflow™ airflow system; SmartClean patented front window cleaning position design; comfortable armrest and low noise.

 

Single-use Equipment

Finesse SmartBag/Smart Rocker

SmartBags can accommodate the cultures at 10-50L; SmartRocker can provide great wave angles to suspend high-density culture cells.

 
 
 

4  Quality Control and Release

Applied Biosystems™ 7500 Fast Dx Real-Time PCR Instrument

It is based on semiconductor refrigeration technology (Peltier thermoelectric module technology) to deliver the performance required for high-quality results in the form of 96-well plates. It can identify 5,000 to 10,000 genomic equivalents (2 times copy number difference) with a confidence level of 99.7%.

Applied Biosystems™ MycoSEQ™ Mycoplasma Detection Kit

High sensitivity and various detection types, meeting the requirements of USP, EP, JP and ICH.

Applied Biosystems™ 3500 Series Genetic Analyzer

It performs fragment analysis and Sanger sequencing, including but not limited to STR/microsatellite analysis, loss of heterozygosity, SNP validation and screening, and ab initio sequencing and resequencing (mutant spectrum analysis). It provides dual-mode functions and is more flexible; it is equipped with powerful and integrated data acquisition and preliminary analysis software, which allows real-time data quality evaluation; it is simple to set up, operate and maintain.

 

Invitrogen™ Countless™ II FL Automated Cell Counter

The benchtop cytometer is equipped with advanced optical components and image analysis software for automated focusing and rapid counting of suspended cells. It is suitable for cells of size 7-60 μm to be counted with this method.

Thermo Scientific™ CellInsight CX7 High-Content Screening (HCS) System

High-resolution automated cell quantification imaging and analysis; used for high-throughput screening of effective T-cell chimeras; efficiently evaluating the killing efficiency of CAR T-cells (the percentage of targeted tumor cells killed), and automatically exporting the analytical data.

Invitrogen™ Attune™ NxT Flow Cytometer

It is a brand-new benchtop flow cytometer with innovative acoustic focusing technology, flexible configuration, up to 4-laser and 14-color system, which is fast and unblocked.

 

Thermo Scientific™ Multiskan ET Kinetic Endotoxin Detector

It adopts a patented optical system and single-channel detection, with a detection wavelength range of 340-850nm, which meets the detection requirements of a variety of limulus/tachypleus amebocyte lysate reagents, and can perform kinetic chromogenic and kinetic turbidimetric detection to ensure high accuracy of readings.

Thermo Scientific™ Varioskan LUX Multimode Microplate Reader

It integrates multiple optical detection technologies, including light absorption, fluorescence, chemiluminescence, time-resolved fluorescence and Alpha, which can meet the detection needs of multiple quality control indicators such as cell viability, toxicity, proliferation, and reporter gene expression.

Thermo Scientific™ Q Exactive Ultra High-Resolution Liquid Chromatography-Mass Spectrometry (LC-MS)

It identifies, confirms and quantifies non-target or target compounds and proteins in a quick and reliable way, and is especially suitable for cell therapy mechanism research, new target discovery and verification, quality control research, and drug packaging material detection.

 

Thermo Scientific™ Vanquish Ultra High-Performance Liquid Chromatography (HPLC)

Built with biologically inert materials, it is more suitable for the isolation and detection of biological sample analysis; with better retention time stability, excellent sensitivity and isolation efficiency, it is designed to meet strict engineering standards, and is adaptable to various detectors, which is especially suitable for cell therapy quality control research and detection of drug packaging materials and dextran 40.

Thermo Scientific™ VersaTREK Automated Microbial Culture System

The automated microbial culture system is approved by FDA and CFDA. With its unique barometric pressure sensor technology and VorTREXing™ vortex culture technology, positive results can be obtained more quickly and sensitively, helping to reduce the risk of microbial contamination.

 
 

Experimental Preparation

Thermo Scientific™ GENEPURE Ultrapure Water Meter

Thermo Scientific™ 88880005 Hot Plate

Thermo Scientific™ 88880018 Vortex Oscillator

 

Thermo Scientific™ Finnpipette F1 Single Channel (Multichannel) Pipette

Thermo Scientific™ S1 Pipette Filler

Thermo Scientific™ PLR-3864°C Laboratory Refrigerator

 

5  Storage and Cold Chain Transportation

Thermo Scientific™ Cyromed Controlled-Rate Freezer

It offers high flexibility of controlled-rate freezing where multiple freezing curves can be customized according to specific solutions.

Thermo Scientific™ CyroExtra40 High-Efficiency Gas Phase Liquid Nitrogen Tank/CyroPlus Liquid Nitrogen Storage Tank

Large storage capacity: 20,000 to 90,000 cryopreservation tubes; gas phase storage, preventing tube bursts, with extremely low probability of contamination; good thermal insulation performance: -190°C ±5°C; liquid nitrogen consumption is equivalent to that of a small liquid nitrogen tank.

Thermo Scientific™ Forma Ultra-Low Temperature Freezer

50% energy saving; quiet, 20 times quieter than traditional Ultra-Low Temperature freezers; long warranty period, 5-year warranty for the whole machine; it is environmentally friendly and uses fluorine-free hydrocarbon refrigerants (ethane and propane), which meets K6 standards.

 

Thermo Scientific™ Arctic Express Sample Transport Tank

The unique material absorbs liquid nitrogen and ensures the transportation of samples at low temperatures below -160°C without any risk of liquid nitrogen leakage. The cryopreservation time is 7-21 days. A dedicated IATA certified high-risk sample transport tank is available.

 
 
 

Thermo Fisher Scientific T-cell Immune Repertoire Solutions

The strategy to realize precision medicine in oncology by influencing an individual’s immune system has always been a common research goal of numerous scientists for many years. However, the complex oncology-immune interactions require multidimensional solutions, so as to achieve well-designed translational studies and analysis of results. Genomics solutions based on the next generation sequencing (NGS) can be a promising powerful tool for driving major discoveries in translational and clinical research.

Using the Ion Torrent long-segment NGS platform to exert the power of immune repertoire research

By analyzing the immune repertoire to obtain the diversity of T-cell receptor (TCR) gene recombination, it can help you make significant advances in immunooncology research. Ion AmpliSeq™ Immune Repertoire Assay Plus and TCR provide a fast, long-segment long-read NGS tool for complex cellular immunology research. This integrated solution includes:

 

Identification of immune response biomarkers

- Accurately measure the diversity and clonal amplification of the T-cell immune repertoire, identify antigen-specific T-cells, and promote translational research.

 

Optimizing the function and production of potential therapeutic T-cells

- Identify the TCR chain sequence, and optimize the production of genetically engineered T-cells.

 

Investigating the markers of immune-mediated adverse events (IMAEs)

- All three complementarity determining regions (CDR1, CDR2, and CDR3) are analyzed for allele-specific polymorphisms in these regions, which may be associated with autoimmune diseases and IMAEs.

 

Based on the reliable and widely referenced Ion AmpliSeq™ technology, our well-designed NGS solution can significantly improve your turnaround time, that is, it only takes 48 hours from samples to results (Figure 1). Ion AmpliSeq Immune Repertoire Assay Plus and TCR can read up to 400 bp amplicon length for complete analysis of CDR1, CDR2, and CDR3 (Figure 2). The mRNA-based sequencing is highly accurate, and the primer bias for PCR introduction is extremely low.

V-genes

Data security

- You can have full control over your data (no service mode and additional fees) and ensure the transparency of analysis. Your TCR sequence is always reserved for you.

 

Accuracy

- With RNA as a starting point, you do not have to worry about recombination of TCR chain genes, and you could benefit from the low replacement error rate of the Ion S5 system.

 

Low sample demand

- Based on your sample situation and requirements, the AmpliSeq library can be constructed just with a sample volume of 10ng-1μg.

 
 

Stem cell therapy

Stem cell is a kind of cell that are not fully differentiated and have not yet matured. They have the potential of self-replication and differentiation and can differentiate into various types of multifunctional cells in the body under certain conditions. Stem cell therapy has become a key research field at international medical frontier, bringing unlimited potential to diseases that cannot be cured by current medical technology. For example, in the field of organ transplantation, stem cells can be differentiated into different types of somatic cells such as hepatic cells, kidney cells, lung cells and heart cells, and finally construct corresponding human organs by means of tissue engineering.

Mesenchymal stem cells

Gibco Cells

StemPro™ BM Mesenchymal Stem Cells *

Cell Customization and Service

Thermo Scientific Cell Culture Plastics

Nunc™ Cell Culture Dishes

Nunc™ Cell FactoryTM System

* Research use only

Gibco Amplification Culture System

CTS StemPro MSC SFM

StemPro MSC SFM Xenofree

CTS CELLstart Substrate

CTS™ GlutaMAX™-I Supplement

CTS TrypLE Select

Custom Media and Services

Gibco Differentiation Medium

StemPro Osteogenesis Differentiation Kit

StemPro Chondrogenesis Differentiation Kit

StemPro Adipogenesis Differentiation Kit

Gibco Growth Factor

CTS TGF-β1

CTS FGF-Basic

Thermo Scientific Single-use Technology

Bioreactor/Lining

Transfer Components

Cell Culture and Biological Production System

Nunc™ Cell Culture Dishes

Invitrogen Gene Modification

MessengerMAXTM Transfection Reagent

LipofectamineTM 3000 Transfection Reagent

LipofectamineTM 2000 CD Transfection Reagent

GeneArt Elements Services

CaptureSelect™ Affinity Matrix

CRISPR-Cas9 Products and Services

Designer TALEN Products and Services

Invitrogen Electroporation Device

Neon Electroporation Transfection System

Thermo Scientific Plastics and Imaging Petri Dishes

Nunc™ Cell FactoryTM system

Nunc™ Plate

Gibco Washing

CTS DPBS

Gibco Cryopreservation Medium

CTS Synth-a-Freeze Medium

Cryopreservation

Nalgene 和Nunc cryotubes

Biobank Services

Thermo Scientific Arctic Express

Sample Transport Tank

Thermo Scientific Forma Ultra-Low Temperature Freezer

Batch release testing

Safety

Identification

Efficacy

Purity

Process characterization analysis

Functional analysis

Cell analysis

Protein analysis

Genetic analysis

 

Mesenchymal stem cell therapy

Gibco™ CTS™ StemPro™ MSC Substrate

Gibco™ CTS™ StemPro™ MSC Serum-free Medium (SFM) - a serum-free medium specially designed for the growth and amplification of human mesenchymal stem cells (MSCs) and human adipose derived stem cells (ADSCs).

  • Excellent consistency in the growth and proliferation of human MSC is achieved compared to the classic serum supplement medium (DMEM + 10% FBS)
  • Using CTS StemPro MSC SFM, human MSC can be amplified for more than 5 generations while its three-line mesodermal differentiation potential is retained
  • Human MSCs cultured in serum-supplemented medium can be directly converted into CTS StemPro MSC SFM with little adaptation

Gibco™ CTS™ CELLstart Substrate

As the first cell culture substrate with fully-defined xeno-free components, it enables adhesion and serum-free amplification of human MSCs, providing an excellent substrate for applications requiring more similar physiological conditions in vivo.

  • It contains only components of human origin (xeno-free) and has stable interbatch performance
  • It helps to maintain the pluripotency, morphology and three-line mesodermal differentiation potential of human MSCs
  • Full traceability of products; reliable production conditions; drug master file filing

Gibco™ StemPro™ Differentiation Kit

It is used for the standardized differentiation of cultured human mesenchymal stem cells (MSCs), supporting the reliable induction of MSCs into chondroblasts, osteoblasts, and adipocytes in serum-free conditions.

  • As a complementary product to CTS StemPro MSC SFM, StemPro MSC SFM XenoFree, and MesenPRO RS Medium as well as MSC-proven FBS Cell Amplification System
  • Each batch has been verified
  • Also can support the differentiation application of rat and mouse MSCs
 

Pluripotent stem cells

Gibco Isolation

(T-cell) CTS Dynabeads CD3/CD28 Beads

Gibco Medium

(T-cell) OpTmizer Medium

(PBMC/CD34 cell)

StemPro™-34 SFM

(Fibroblast) CTS™ KnockOut™

SR Xenofree

Gibco Decomposition Reagent

CTS™ TrypLE™ Select Enzyme

Invitrogen Reprogramming Kit

CytoTune™-iPS 2.0 Sendai Reprogramming Kit

Invitrogen Transfection Reagent

(Fibroblast) Lipofectamine™ 3000 Transfection Reagent

Invitrogen Electroporation Device

(T-cell) Neon Electroporation Transfection System

Gibco cryopreservation

CTS Synth-a-Freeze Medium

PSC Cryopreservation kit

RevitaCell™ Supplement

Essential 8 / CTS VTN

rh-Laminin 521

Gibco Proliferation Medium System

CTS™KnockOut™ SR, XenoFree

CTS™ KnockOut™ DMEM/F-12

CTS KnockOut SR

CTS™ CELLstart™ Substrate

Essential 8TM Medium/CTS VTN

EDTA / Versene

RevitaCell™ Supplement

Essential 8 / CTS VTN

rh-Laminin 521

Medium Customization and Services

Invitrogen Gene Editing

CRISPR-Cas9 Products and Services

DesignerTALEN Products and Services

Liposome Transfection Reagent

Lipofectamine™ MessengerMAX™

Transfection Reagent

Thermo Scientific Single-use Technology

Bioprocess Containers (BPCs)

Transfer Components

Electrostatic Discharge (ESD) Bags

Wave Culture Bags

Nunc

Gibco Differentiation Reagent

PSC Cardiomyocyte Differentiation Kit

PSC Dopaminergic Neuron Differentiation Kit

PSC Definitive Endoderm Induction Kit

CTS™ B-27 Supplement, XenoFree

CTS™ N-2 Supplement

CTS KnockOut DMEM / F-12

CTS™ Neurobasal™ Medium

CTS™ Neurobasal™-A Medium

CTS™ Neurobasal™-A Medium

CultureOne™ Supplement

Gibco Growth Factor

CTS™ TGF-β1

CTS™ Stem Cell Factor (SCF)

CTS™ FLT 3 Ligand

CTS™ FGF Basic Full Length

Gibco Washing

CTS DPBS

Gibco Cryopreservation Medium

CTS Synth-a-Freeze Medium

Cryopreservation and Logistics

Nalgene™ and Nunc™ Cryogenic Tubes

Biobank Services

 

Pluripotent stem cell therapy

Gibco™ Essential 8™ Series Medium

Gibco Essential 8 Series Medium is a serum-free, xeno-free, and feeder-free medium developed on the basis of James Thomas. It contains only 8 essential components necessary for maintaining the growth and amplification of pluripotent stem cells, supports iPSC culture for more than 50 generations without any abnormal signs of cell karyotype, and can maintain the ability of iPSCs to differentiate into all three embryonic lineages.

  • Stable - Xeno-free components and in compliance with cGMP requirements
  • Consistent - Smaller difference between batches compared to the existing feeder-free medium
  • Flexible - This series also provides Essential 6 for embryoid body formation and differentiation applications, and provides the Essential 8 Flex with flexible feeding methods and the CTS Essential 8 medium which is well suited for stem cell transformation applications and is completely human- and animal-origin free (AOF)

Gibco™ CTS™ Vitronectin (VTN-N) Recombinant Human Protein

It provides a definitive surface for feeder-free cell culture of PSCs.

  • Reduces animal-origin, variability and risk of contamination in PSC cultures
  • Provides an excellent environment for feeder-free pluripotent stem cell culture, as the VTN-N variant has been shown to be better than wild-type vitronectin in supporting human PSC attachment and survival
 

Hematopoietic stem cells

Gibco Isolation

Dynabeads CD34 Positive Isolation Kit

DynaMag Magnetic Stand

Thermo Scientific Cell Culture Plastics

Nunc™ Cell Culture Dishes

Gibco Expansion Medium System

StemPro-34 SFM

Custom Media and Services

CTS™GlutaMAX™-I Supplement

Gibco Growth Factor

CTS IL-2, IL-3, CTS IL-4, IL-5, CTS IL-6, CTS IL-7, CTS GM-CSF, CTS SCF, CTS FLT3 ligand, TPO, M-CSF

Thermo Scientific Single-use Technology

Bioreactor/Lining

Transfer Components

Cell Culture and Biological Production System

Nunc™ Cell Culture Dishes

Gibco Washing

CTS DPBS

Gibco Cryopreservation Medium

CTS Synth-a-Freeze Medium

Cryopreservation

Nalgene 和Nunc cryotubes

Biobank Services

Batch release testing

Safety

Identification

Efficacy

Purity

Process characterization analysis

Functional analysis

Cell analysis

Protein analysis

Genetic analysis

 

Hematopoietic stem cell therapy

StemPro™-34 Serum-free Medium (SFM)

The serum-free medium is specially designed for the culture of human hematopoietic stem cells (e.g., CD34+), which is suitable for the culture and subsequent applications of HSC isolated from human bone marrow, peripheral blood or neonatal umbilical cord blood. Compared with the classical serum-attached medium (IMDM + FBS and cytokines), the medium produces better cell amplification effect. The medium contains no cytokines or growth factors, and the components and flexible combination of variables can be adjusted according to your research needs.

Dynabeads™ CD34 Positive Isolation Kit

It is used to isolate a high purity and yield of human CD34 + progenitor stem cells.

Human CD34 + progenitor stem cells can be isolated directly from whole or umbilical cord blood or bone marrow using the bead release method, and the isolated CD34+ cells can be used for any application (i.e., they can differentiate into dendritic cells or natural killer cells).

 

Platform for Science

Digital sample tracking solutions for cell therapy

“Digital solutions have become a global trend, and we have been actively promoting the development of digital solutions in China. Thermo Fisher Scientific has always been committed to the development strategy of ‘in China, for China’. We look forward to leveraging our expertise in cell therapy and digital solutions to improve industry standards, accelerate the development of cell therapy in China, and provide affordable therapeutic regimens for Chinese patients.”

—— Tony Acciarito, President of Greater China, Thermo Fisher Scientific

Thermo Fisher Scientific digital solutionsProduct features
Sample location trackingSample temperature trackingData storage and audit trailData analysis and report generationProcess analysis managementR&D process optimizationProduction batch management (including production execution system for materials, personnel, equipment, documents, etc.)Equipment automation (data collection and central control)
SmartTracker    
SmartLab  
(Tracking the production process only)

(Tracking the production process only)
  
SmartFactory  
(Tracking the production process only)

(Tracking the production process only)
 

Important value of cloud-based Platform for Science

  • Storage of all data in a single platform architecture helps simplify analysis and provides a single source of facts
  • Functions can be easily added at any time through applications, solution sets, and configurations, without the need to write custom code
  • Supporting the use of industry-leading Core OData API to extend the platform to integrate advanced equipment

Platform for Science suitable for scientific data capture, management and analysis

Implemented Platform Methods

The Core layered solution stack shows how applications and products running on the same underlying code base, the Platform for Science, work together. All modifications to the Core solution are completed through configuration, without writing custom code, and are immediately available on the entire platform or through the Core OData API.
Application
The solution focuses on providing modular applications. Applications are composable and the designs are reusable, thus users can rearrange the applications to suit the specific requirements of the workflow.
Product
All the traditional data management products (LIMS, ELN and SDMS) you know about are now integrated into one platform, and products that require collaboration and integration between software systems are integrated.
Platform
The Platform for Science is a flexible “Platform as a Service” (PaaS), which is the foundation of all software products and applications. Solutions and configurations can be added quickly, meanwhile effective communication between products on the entire platform are supported.
 

Accelerating clinical trials - ensuring the quality of clinical drugs is our core value

Understand that patients are waiting for the clinical trial drugs provided by us, especially biologics that are sensitive to transportation time and temperature


A Thermo Fisher Scientific Brand
 

Internationally verified professional logistics services, including

Dedicated to the shipment of time-sensitive clinical trial drugs and biologics for customers, including cold chain solutions, global SOP standards compliance, transportation time shortening, and sample tracking. The scope of application covers research and development of drugs, Phase I to Phase III clinical trials, and commercialization (DTP-DTR-Ph IV), providing accurate logistics information for APIs, clinical trial materials, research samples and vaccines, biosimilars and cell therapies.

Additional services

NFO, charter services, import and export license management and link establishment, cold chain supply and management

Service commitment

Follow global SOPs, global GxP network, round-the-clock freight services, internal audit, and global enterprise-level quality control management committee

 

Fisher clinical trial services are designed to support customers from early stage and later stage trials to commercialization. We will provide full-process services for clinical trials, from clinical production, label design and packaging, storage and supply chain to reverse logistics and destruction. Meanwhile, we also provide auxiliary equipment management and comparator sourcing, biobank storage, total transportation management, and clinical supply optimization services for customers requiring supply chain management or other requirements planning.

Cell quality control

Cell products are ultimately used in the human body, therefore specific quality standards need to be established for quality control. Specifically, the whole process of donor screening, tissue grading, cell isolation, culture, cryopreservation, resuscitation, release, transportation and use requires quality control to ensure the stability, effectiveness and safety of the product.

According to the Points of Consideration for the Application of Clinical Trial Pharmaceutical Research and Application Materials for Cell Therapy Products recently published by the CDE, the applicant is requested to pay special attention to the following points of consideration for pharmaceutical research and application materials on the basis of carrying out relevant research in accordance with the technical guidelines. Among which, quality research (plasmids, viruses, and CAR T-cells) focuses on safety-related projects and conducts risk assessment, especially quality standards for plasmids, viruses, and CAR-T products.

 Determination itemsDetermination methodsThermo Fisher Scientific ’s Equipment or Kits
Plasmid QCpH valueDetermination of pH meterVERSA STAR ProTM Benchtop pH Meter and patented ROSS pH electrodes
Plasmid contentUltraviolet spectrometryNanoDrop™ 3300 Fluorospectrometer
260/280 purityMultiskan Sky Nucleic Acid Protein Analyzer
 Qubit 4 Fluorometer + Reagents
Plasmid DNA homogeneityAgarose electrophoresisE-Gel Precast Agarose Gel Electrophoresis System + Reagents
Genetic sequencingSequencing3500 Dx/SeqStudio Genetic Analyzer
SterilityMicrobial Culture SystemVersaTREK Automated Microbial Culture System
No endotoxinPhotometryMultiskan Microplate Reader + Reagents
Host RNA residueqPCRPowerUp™ SYBR™ Green
TaqMan™ Fast Advanced Master Mix
7500 DX Fast Real-Time PCR System
QuantStudio™ Dx Real-Time PCR system
Host gene residueqPCRresDNASEQ® E. coli Residual DNA Quantitation System and resDNASEQ® Human Residual DNA Quantitation Kit
7500 DX Fast Real-Time PCR System
QuantStudio™ Dx Real-Time PCR system
DNA probe hybridizationE-Gel Precast Agarose Gel Electrophoresis System + Reagents
Host protein residueELISAMultiskan Sky Nucleic Acid Protein Analyzer
 BCA Kit
 Determination itemsDetermination methodsThermo Fisher Scientific ’s Equipment or Kits
Viral vector QCpH valueDetermination of pH meterVERSA STAR ProTM Benchtop pH Meter and patented ROSS pH electrodes
Osmotic pressure molar concentrationDetermination by the molar concentration meterAdvance 3250 Single-Sample Osmometer
CAR gene identificationqPCRApplied Biosystems™ 3500 Series Genetic Analyzer
Virus titerPhysicochemical determination - qPCR7500 DX Fast Real-Time PCR System
Biological function determination - ELISAVarioskan LUX
DNA residueqPCRresDNASEQ® E. coli Residual DNA Quantitation System and resDNASEQ® Human Residual DNA Quantitation Kit
7500 DX Fast Real-Time PCR System
QuantStudio™ Dx Real-Time PCR System
DNA probe hybridizationE-Gel Precast Agarose Gel Electrophoresis System + Reagents
Residual host DNA transfer (SV40, E1A, etc.)qPCR7500 DX Fast Real-Time PCR System
QuantStudio™ Dx Real-Time PCR System
Conventional PCRProFlex™ Thermal Cycler
E-Gel Precast Agarose Gel Electrophoresis System + Reagents
Protein residueELISAMultiskan Sky Nucleic Acid Protein Analyzer
BCA Kit
BSA residue Multiskan Sky Nucleic Acid Protein Analyzer
BCA Kit
Nuclease residue Multiskan Sky Nucleic Acid Protein Analyzer
BCA Kit
RNaseAlert® QC System v2
DNaseAlert™ QC System
RCR/RCLqPCR7500 DX Fast Real-Time PCR System
QuantStudio™ Dx Real-Time PCR System
SterilityMicrobial Culture SystemSterile Microbial Culture System VersaTREK
Automated Microbial Culture System
No endotoxinPhotometryMultiskan Microplate Reader + Reagents
MycoplasmaqPCRMycoSEQ Mycoplasma Detection Kit
7500 DX Fast Real-Time PCR System
QuantStudio™ Dx Real-Time PCR System
DNA stainingDNA Staining Evos XL
Exogenous virus detectionCell morphology observation and hemadsorption testInvitrogen™ EVOS™ microscope for exogenous virus detection cell morphology observation and hemadsorption test
 Determination itemsDetermination methodsThermo Fisher Scientific’s Equipment or Kits
CAR T-cell product QCpH valuepH meterpH Meter, VERSA STAR Protm Benchtop pH Meter and patented ROSS pH electrodes
Osmotic pressureOsmometerAdvanced Model 3250 Single-Sample Osmometer
Viable cell densityFlow cytometer + dyeAttune NxT
Dead/Live Dye
Cell viabilityFlow cytometer + dyeAttune NxT
Sytox Series Dyes or PI, etc.
Proportion of CD3+T-cellsFlow cytometer + antibodyAttune NxT
Human CD3 Antibody
CD3+CRT+ cellsFlow cytometer + antibodyAttune NxT
Human CD3 Antibody and Secondary Antibody
Proportion of unrelated cellsFlow cytometer + antibodyAttune NxT
Cell typingFlow cytometer + antibodyAttune NxT
Different Flow Antibody
BioactivityDyeDye Vybrant™ MTT Cell Proliferation Assay Kit + MTT
MTT stainingVarioskan LUX Multimode Microplate Reader
MTT stainingThermo Scientific Multiskan SkyHigh Microplate Spectrophotometer
Cell countCell counterInvitrogen™ II FL Automated Cell Counter
RCR/RCLqPCR instrument7500 DX Fast Real-Time PCR System
Vector copy number QuantStudio™ Dx Real-Time PCR System
SterilityMicrobial rapid culture systemVersaTREK Automated Microbial Culture System
Identification of microbial strainsRapID Rapid Identification Strip
Identification of microbial strainsARIS 2X Automated Microbial Identification and Drug Sensitivity Analysis System
No endotoxinMicroplate reader + limulus/tachypleus amebocyte lysate reagentMultiskan ET Reader + Reagents
MycoplasmaMycoplasma Detection Kit for qPCR instrumentsMycoSEQ Mycoplasma Detection Kit
7500 DX Fast Real-Time PCR System
QuantStudio™ Dx Real-Time PCR System
Magnetic bead residueOptical microscopeInvitrogen™ EVOS™ Microscope

Tools for in-process quality control and interbatch testing

Invitrogen™ Attune™ NxT Flow Cytometer

A tool for in-process and interbatch testing - a true benchtop flow cytometer that blends precision with performance, with up to 4 lasers and 16 test parameters.

  • Anti-blocking design, acoustic focusing cytometry technology and high-quality fluid technology help prevent the loss of valuable samples and enable the analysis of hard-to-analyze samples such as tumors
  • 10 times faster than other flow cytometers and can provide superior data fidelity
  • The plate autosampler can achieve true automation on conventional and 96- or 384-well deep well plates

 
Functions of Invitrogen™ Attune™ NxT Flow Cytometer
Cell viabilitySelect Invitrogen™ viability staining analysis
Plasmid Content

Invitrogen™ Click-iT™ EdU detection provides:

  • Quantification of newly synthesized DNA
  • No DNA degeneration was detected
  • Compatible with sensitive R-PE tandems and fluorescent proteins
  • Replace cumbersome BrdU detection
Detection of Cell Populations

Cells are permanently labeled with fluorescent staining to track generation or division without affecting morphology or physiology. Invitrogen™ CellTrace™ Cell Proliferation Kit provides:

  • Cell tracking in vitro or in vivo
  • Bright unimodal staining
  • Long-term signal stability

Applied Biosystems™ MycoSEQ™ Mycoplasma Detection Kit

It can achieve highly sensitive, specific and overall detection of more than 90 mycoplasma species. These kits are specifically designed for routine screening and detection of mycoplasma and closely related species, such as Acholeplasma laidlawii and Spiroplasma citri, and are in compliance with European Pharmacopoeia guidelines.

  • Highly optimized sample preparation; test results are verified during the same day (results are usually obtained within < 5 hours)
  • Widely used and validated by biopharmaceutical users
  • App support is included to guide you through the validation process
  • The detection sensitivity is proven to be < 10 CFU/mL

 

Environmental Monitoring

1. Monitoring of planktonic bacteria

Thermo Scientific Air Sampler

  • Flexibility: The sampler accepts either a native built-in program or a user-defined program, providing flexibility in sampling volume, delayed start, multi-functional running and interval sampling.
  • Acquisition efficiency: The validation work carried out by an independent laboratory in accordance with BS EN ISO 14698-1:2003 has shown that the air sampler has achieved 100% physical acquisition efficiency for particles within the range of 0.8 to 19.0 microns.
  • Data processing: Sampling records can be stored and data can be downloaded to a computer for reporting and trend analysis.
  • Calibration services available
 

2. Plates for monitoring the planktonic bacteria and settling bacteria

  • Prepared with high-quality Oxoid dry powder medium: Tryptone soya agar (TSA) medium, sabouraud dextrose agar (SDA) medium or other media are available
  • Three layers of sterile packaging products; does not require 100% preculture

3.1 Surface Monitoring Contact Plate

  • It can be used to sample and cultivate microorganisms on the surface of equipment, floors, walls, countertops, human hands, clothes, etc.
  • Three layers of sterile packaging products, does not require 100% preculture
 

3.2 Contact Plate Controller

  • Standardized microbial surface control sampling process
  • Suitable for contact plates of different specifications; able to perform up to 10 seconds of standardized sampling with a weight of 500g, with acoustic and visual cues
 
 

Final Product Low-temperature Microbial Culture

RI Series Low-Temperature Incubator

  • Temperature range of 4-60°C, temperature uniformity ≤ ±0.8°C (@20°C), temperature deviation ≤ ±0.3°C (@20°C), precise temperature control and repeatable experimental results
  • Reliable and stable compressor refrigeration technology, automated defrosting, which is suitable for long-term applications below ambient temperature
  • Convenient sample viewing through the observation window on the door; the standard access port and timing function on the right side is a great convenience to users

IMP Series Low-Temperature Incubator

  • Provide a temperature range of 5-70°C, with benchtop and floor-standing models available, temperature uniformity of ±0.3°C (@25°C), and temperature stability of ±0.1°C, ensuring good experimental reproducibility
  • Peltier semiconductor refrigeration technology saves more than 80% energy than conventional compressor models, ensuring temperature uniformity and stability, with extremely low vibration, and optimized temperature distribution for the inner cavity fan
  • DIN12880 Class2.0 adjustable over-temperature protection function, and the over-temperature automated heating cut-off is an extremely high guarantee for safe applications
  • Intuitive programming function; up to 10 stored programs; daily/weekly/real-time precise timing; extremely easy operation
 

Consultancy on the construction of new laboratories and plants for the preparation of CAR T-cells

From laboratory research, pilot plant to mass production, Thermo Fisher Scientific helps you build your laboratory starting from site planning and process setting with reference to GLP and GMP regulations, and maintain consistency of processes and results during the scaling up process.

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