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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.
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.
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:
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.
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.
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.
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
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.
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.
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.
Figure 1. Workflow. After constructing the library manually, the Ion Chef™ system is used for automated template preparation, IonS5 system for sequencing, and Ion Reporter software for data analysis.
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
Figure 2. The histogram shows the V-genes between clones in a sample.
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 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
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).
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 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.
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
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.
It provides a definitive surface for feeder-free cell culture of PSCs.
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
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.
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).
“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 tracking | Sample temperature tracking | Data storage and audit trail | Data analysis and report generation | Process analysis management | R&D process optimization | Production batch management (including production execution system for materials, personnel, equipment, documents, etc.) | Equipment automation (data collection and central control) |
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SmartTracker | ![]() | ![]() | ![]() | ![]() | ||||
SmartLab | ![]() (Tracking the production process only) | ![]() (Tracking the production process only) | ![]() | ![]() | ||||
SmartFactory | ![]() (Tracking the production process only) | ![]() (Tracking the production process only) | ![]() | ![]() | ![]() |
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 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 items | Determination methods | Thermo Fisher Scientific ’s Equipment or Kits | |
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Plasmid QC | pH value | Determination of pH meter | VERSA STAR ProTM Benchtop pH Meter and patented ROSS pH electrodes |
Plasmid content | Ultraviolet spectrometry | NanoDrop™ 3300 Fluorospectrometer | |
260/280 purity | Multiskan Sky Nucleic Acid Protein Analyzer | ||
Qubit 4 Fluorometer + Reagents | |||
Plasmid DNA homogeneity | Agarose electrophoresis | E-Gel Precast Agarose Gel Electrophoresis System + Reagents | |
Genetic sequencing | Sequencing | 3500 Dx/SeqStudio Genetic Analyzer | |
Sterility | Microbial Culture System | VersaTREK Automated Microbial Culture System | |
No endotoxin | Photometry | Multiskan Microplate Reader + Reagents | |
Host RNA residue | qPCR | PowerUp™ SYBR™ Green | |
TaqMan™ Fast Advanced Master Mix | |||
7500 DX Fast Real-Time PCR System | |||
QuantStudio™ Dx Real-Time PCR system | |||
Host gene residue | qPCR | resDNASEQ® 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 hybridization | E-Gel Precast Agarose Gel Electrophoresis System + Reagents | ||
Host protein residue | ELISA | Multiskan Sky Nucleic Acid Protein Analyzer | |
BCA Kit |
Determination items | Determination methods | Thermo Fisher Scientific ’s Equipment or Kits | |
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Viral vector QC | pH value | Determination of pH meter | VERSA STAR ProTM Benchtop pH Meter and patented ROSS pH electrodes |
Osmotic pressure molar concentration | Determination by the molar concentration meter | Advance 3250 Single-Sample Osmometer | |
CAR gene identification | qPCR | Applied Biosystems™ 3500 Series Genetic Analyzer | |
Virus titer | Physicochemical determination - qPCR | 7500 DX Fast Real-Time PCR System | |
Biological function determination - ELISA | Varioskan LUX | ||
DNA residue | qPCR | resDNASEQ® 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 hybridization | E-Gel Precast Agarose Gel Electrophoresis System + Reagents | ||
Residual host DNA transfer (SV40, E1A, etc.) | qPCR | 7500 DX Fast Real-Time PCR System | |
QuantStudio™ Dx Real-Time PCR System | |||
Conventional PCR | ProFlex™ Thermal Cycler | ||
E-Gel Precast Agarose Gel Electrophoresis System + Reagents | |||
Protein residue | ELISA | Multiskan 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/RCL | qPCR | 7500 DX Fast Real-Time PCR System | |
QuantStudio™ Dx Real-Time PCR System | |||
Sterility | Microbial Culture System | Sterile Microbial Culture System VersaTREK Automated Microbial Culture System | |
No endotoxin | Photometry | Multiskan Microplate Reader + Reagents | |
Mycoplasma | qPCR | MycoSEQ Mycoplasma Detection Kit | |
7500 DX Fast Real-Time PCR System | |||
QuantStudio™ Dx Real-Time PCR System | |||
DNA staining | DNA Staining Evos XL | ||
Exogenous virus detection | Cell morphology observation and hemadsorption test | Invitrogen™ EVOS™ microscope for exogenous virus detection cell morphology observation and hemadsorption test |
Determination items | Determination methods | Thermo Fisher Scientific’s Equipment or Kits | |
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CAR T-cell product QC | pH value | pH meter | pH Meter, VERSA STAR Protm Benchtop pH Meter and patented ROSS pH electrodes |
Osmotic pressure | Osmometer | Advanced Model 3250 Single-Sample Osmometer | |
Viable cell density | Flow cytometer + dye | Attune NxT | |
Dead/Live Dye | |||
Cell viability | Flow cytometer + dye | Attune NxT | |
Sytox Series Dyes or PI, etc. | |||
Proportion of CD3+T-cells | Flow cytometer + antibody | Attune NxT | |
Human CD3 Antibody | |||
CD3+CRT+ cells | Flow cytometer + antibody | Attune NxT | |
Human CD3 Antibody and Secondary Antibody | |||
Proportion of unrelated cells | Flow cytometer + antibody | Attune NxT | |
Cell typing | Flow cytometer + antibody | Attune NxT | |
Different Flow Antibody | |||
Bioactivity | Dye | Dye Vybrant™ MTT Cell Proliferation Assay Kit + MTT | |
MTT staining | Varioskan LUX Multimode Microplate Reader | ||
MTT staining | Thermo Scientific Multiskan SkyHigh Microplate Spectrophotometer | ||
Cell count | Cell counter | Invitrogen™ II FL Automated Cell Counter | |
RCR/RCL | qPCR instrument | 7500 DX Fast Real-Time PCR System | |
Vector copy number | QuantStudio™ Dx Real-Time PCR System | ||
Sterility | Microbial rapid culture system | VersaTREK Automated Microbial Culture System | |
Identification of microbial strains | RapID Rapid Identification Strip | ||
Identification of microbial strains | ARIS 2X Automated Microbial Identification and Drug Sensitivity Analysis System | ||
No endotoxin | Microplate reader + limulus/tachypleus amebocyte lysate reagent | Multiskan ET Reader + Reagents | |
Mycoplasma | Mycoplasma Detection Kit for qPCR instruments | MycoSEQ Mycoplasma Detection Kit | |
7500 DX Fast Real-Time PCR System | |||
QuantStudio™ Dx Real-Time PCR System | |||
Magnetic bead residue | Optical microscope | Invitrogen™ EVOS™ Microscope |
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.
Functions of Invitrogen™ Attune™ NxT Flow Cytometer | |
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Cell viability | Select Invitrogen™ viability staining analysis |
Plasmid Content | Invitrogen™ Click-iT™ EdU detection provides:
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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:
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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.
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.
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:
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.
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.
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.
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
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.
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.
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.
Figure 1. Workflow. After constructing the library manually, the Ion Chef™ system is used for automated template preparation, IonS5 system for sequencing, and Ion Reporter software for data analysis.
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
Figure 2. The histogram shows the V-genes between clones in a sample.
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 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
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).
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 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.
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
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.
It provides a definitive surface for feeder-free cell culture of PSCs.
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
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.
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).
“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 tracking | Sample temperature tracking | Data storage and audit trail | Data analysis and report generation | Process analysis management | R&D process optimization | Production batch management (including production execution system for materials, personnel, equipment, documents, etc.) | Equipment automation (data collection and central control) |
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SmartTracker | ![]() | ![]() | ![]() | ![]() | ||||
SmartLab | ![]() (Tracking the production process only) | ![]() (Tracking the production process only) | ![]() | ![]() | ||||
SmartFactory | ![]() (Tracking the production process only) | ![]() (Tracking the production process only) | ![]() | ![]() | ![]() |
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 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 items | Determination methods | Thermo Fisher Scientific ’s Equipment or Kits | |
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Plasmid QC | pH value | Determination of pH meter | VERSA STAR ProTM Benchtop pH Meter and patented ROSS pH electrodes |
Plasmid content | Ultraviolet spectrometry | NanoDrop™ 3300 Fluorospectrometer | |
260/280 purity | Multiskan Sky Nucleic Acid Protein Analyzer | ||
Qubit 4 Fluorometer + Reagents | |||
Plasmid DNA homogeneity | Agarose electrophoresis | E-Gel Precast Agarose Gel Electrophoresis System + Reagents | |
Genetic sequencing | Sequencing | 3500 Dx/SeqStudio Genetic Analyzer | |
Sterility | Microbial Culture System | VersaTREK Automated Microbial Culture System | |
No endotoxin | Photometry | Multiskan Microplate Reader + Reagents | |
Host RNA residue | qPCR | PowerUp™ SYBR™ Green | |
TaqMan™ Fast Advanced Master Mix | |||
7500 DX Fast Real-Time PCR System | |||
QuantStudio™ Dx Real-Time PCR system | |||
Host gene residue | qPCR | resDNASEQ® 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 hybridization | E-Gel Precast Agarose Gel Electrophoresis System + Reagents | ||
Host protein residue | ELISA | Multiskan Sky Nucleic Acid Protein Analyzer | |
BCA Kit |
Determination items | Determination methods | Thermo Fisher Scientific ’s Equipment or Kits | |
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Viral vector QC | pH value | Determination of pH meter | VERSA STAR ProTM Benchtop pH Meter and patented ROSS pH electrodes |
Osmotic pressure molar concentration | Determination by the molar concentration meter | Advance 3250 Single-Sample Osmometer | |
CAR gene identification | qPCR | Applied Biosystems™ 3500 Series Genetic Analyzer | |
Virus titer | Physicochemical determination - qPCR | 7500 DX Fast Real-Time PCR System | |
Biological function determination - ELISA | Varioskan LUX | ||
DNA residue | qPCR | resDNASEQ® 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 hybridization | E-Gel Precast Agarose Gel Electrophoresis System + Reagents | ||
Residual host DNA transfer (SV40, E1A, etc.) | qPCR | 7500 DX Fast Real-Time PCR System | |
QuantStudio™ Dx Real-Time PCR System | |||
Conventional PCR | ProFlex™ Thermal Cycler | ||
E-Gel Precast Agarose Gel Electrophoresis System + Reagents | |||
Protein residue | ELISA | Multiskan 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/RCL | qPCR | 7500 DX Fast Real-Time PCR System | |
QuantStudio™ Dx Real-Time PCR System | |||
Sterility | Microbial Culture System | Sterile Microbial Culture System VersaTREK Automated Microbial Culture System | |
No endotoxin | Photometry | Multiskan Microplate Reader + Reagents | |
Mycoplasma | qPCR | MycoSEQ Mycoplasma Detection Kit | |
7500 DX Fast Real-Time PCR System | |||
QuantStudio™ Dx Real-Time PCR System | |||
DNA staining | DNA Staining Evos XL | ||
Exogenous virus detection | Cell morphology observation and hemadsorption test | Invitrogen™ EVOS™ microscope for exogenous virus detection cell morphology observation and hemadsorption test |
Determination items | Determination methods | Thermo Fisher Scientific’s Equipment or Kits | |
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CAR T-cell product QC | pH value | pH meter | pH Meter, VERSA STAR Protm Benchtop pH Meter and patented ROSS pH electrodes |
Osmotic pressure | Osmometer | Advanced Model 3250 Single-Sample Osmometer | |
Viable cell density | Flow cytometer + dye | Attune NxT | |
Dead/Live Dye | |||
Cell viability | Flow cytometer + dye | Attune NxT | |
Sytox Series Dyes or PI, etc. | |||
Proportion of CD3+T-cells | Flow cytometer + antibody | Attune NxT | |
Human CD3 Antibody | |||
CD3+CRT+ cells | Flow cytometer + antibody | Attune NxT | |
Human CD3 Antibody and Secondary Antibody | |||
Proportion of unrelated cells | Flow cytometer + antibody | Attune NxT | |
Cell typing | Flow cytometer + antibody | Attune NxT | |
Different Flow Antibody | |||
Bioactivity | Dye | Dye Vybrant™ MTT Cell Proliferation Assay Kit + MTT | |
MTT staining | Varioskan LUX Multimode Microplate Reader | ||
MTT staining | Thermo Scientific Multiskan SkyHigh Microplate Spectrophotometer | ||
Cell count | Cell counter | Invitrogen™ II FL Automated Cell Counter | |
RCR/RCL | qPCR instrument | 7500 DX Fast Real-Time PCR System | |
Vector copy number | QuantStudio™ Dx Real-Time PCR System | ||
Sterility | Microbial rapid culture system | VersaTREK Automated Microbial Culture System | |
Identification of microbial strains | RapID Rapid Identification Strip | ||
Identification of microbial strains | ARIS 2X Automated Microbial Identification and Drug Sensitivity Analysis System | ||
No endotoxin | Microplate reader + limulus/tachypleus amebocyte lysate reagent | Multiskan ET Reader + Reagents | |
Mycoplasma | Mycoplasma Detection Kit for qPCR instruments | MycoSEQ Mycoplasma Detection Kit | |
7500 DX Fast Real-Time PCR System | |||
QuantStudio™ Dx Real-Time PCR System | |||
Magnetic bead residue | Optical microscope | Invitrogen™ EVOS™ Microscope |
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.
Functions of Invitrogen™ Attune™ NxT Flow Cytometer | |
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Cell viability | Select Invitrogen™ viability staining analysis |
Plasmid Content | Invitrogen™ Click-iT™ EdU detection provides:
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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:
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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.