Reduce risk, save time, and secure supply chain

Pharmaceutical manufacturers must meet the most stringent manufacturing and production standards, starting with highest quality raw materials, to ensure safety of their drugs or vaccines. Read these case studies to learn more about how our Thermo Scientific TheraPure product quality helps minimize regulatory burden and scaling up to meet global demand for critical raw material.

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Scaling up manufacturing when it’s needed most

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Critical pharmaceutical-grade raw materials needed to produce SARS-CoV-2 mRNA therapeutic candidate
Specific goals:

  • Scaling-up raw material needed for  SARS-CoV-2 vaccine - requiring scale of processes and infrastructure without interrupting existing manufacturing
  • Supply proportional amounts of nucleotides and all enzymes needed for mRNA production by in vitro transcription (IVT).
  • Manufacture all enzymes and nucleotides at appropriate scale simultaneously, to meet emergency demand

Thermo Fisher Scientific supplied TheraPure nucleotides and enzymes for early therapeutic development

  • Translated small-scale enzyme manufacturing processes into intermediate-scale single-use system (SUS) processes to further fortify IVT
  • Invested in a new, state-of-the-art manufacturing facility in Vilnius, Lithuania, to meet quality and scale standards 
  • Produced TheraPure products at industrial-scale in full compliance with ISO 13485 quality management systems

Thermo Fisher Scientific supplied the first commercial batches of critical nucleotides and IVT enzymes by November 2020, meeting global needs

  • Absorbed significant risk  to ensure future supply of raw materials to the client
  • Accelerated scale-up at an unprecedented pace for the industry to help ensure the needs of pharmaceutical client and future partnerships
Situation

Critical pharmaceutical-grade raw materials needed to produce SARS-CoV-2 mRNA therapeutic candidate
Specific goals:

  • Scaling-up raw material needed for  SARS-CoV-2 vaccine - requiring scale of processes and infrastructure without interrupting existing manufacturing
  • Supply proportional amounts of nucleotides and all enzymes needed for mRNA production by in vitro transcription (IVT).
  • Manufacture all enzymes and nucleotides at appropriate scale simultaneously, to meet emergency demand
Solution

Thermo Fisher Scientific supplied TheraPure nucleotides and enzymes for early therapeutic development

  • Translated small-scale enzyme manufacturing processes into intermediate-scale single-use system (SUS) processes to further fortify IVT
  • Invested in a new, state-of-the-art manufacturing facility in Vilnius, Lithuania, to meet quality and scale standards 
  • Produced TheraPure products at industrial-scale in full compliance with ISO 13485 quality management systems
Value delivered

Thermo Fisher Scientific supplied the first commercial batches of critical nucleotides and IVT enzymes by November 2020, meeting global needs

  • Absorbed significant risk  to ensure future supply of raw materials to the client
  • Accelerated scale-up at an unprecedented pace for the industry to help ensure the needs of pharmaceutical client and future partnerships

Breaking new ground on animal origin-free reagents

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In 2014, a  bio-pharma client developing a nucleic acid therapy needed enzymes manufactured in animal origin–free (AOF) conditions.

  • True AOF reagents produced at relevant scales were uncommon in the industry
  • Develop and execute manufacturing processes to deliver AOF enzymes at scale

Dedicated team consisted of R&D and manufacturing scientists quickly generated samples of key enzymes for the client to verify in their AOF mRNA production processes

  • AOF enzymes had the same performance and stability as animal origin enzymes
  • Issued a change notification (to regulatory bodies and clients) and developed a custom specification for this new AOF designation
  • Completed a series of audits to help certify AOF enzyme production and secure regulatory risk reduction

Client has adopted AOF enzymes into their mRNA bioproduction processes for manufacturing a variety of therapeutic candidates, reducing risk and regulatory burden in clinical trials

  • A direct connection with highly skilled team of scientists to discuss scientific challenges
  • A dedicated project team including R&D scientists to help ensure successful delivery of product to expectations
Situation

In 2014, a  bio-pharma client developing a nucleic acid therapy needed enzymes manufactured in animal origin–free (AOF) conditions.

  • True AOF reagents produced at relevant scales were uncommon in the industry
  • Develop and execute manufacturing processes to deliver AOF enzymes at scale
Solution

Dedicated team consisted of R&D and manufacturing scientists quickly generated samples of key enzymes for the client to verify in their AOF mRNA production processes

  • AOF enzymes had the same performance and stability as animal origin enzymes
  • Issued a change notification (to regulatory bodies and clients) and developed a custom specification for this new AOF designation
  • Completed a series of audits to help certify AOF enzyme production and secure regulatory risk reduction
Value delivered

Client has adopted AOF enzymes into their mRNA bioproduction processes for manufacturing a variety of therapeutic candidates, reducing risk and regulatory burden in clinical trials

  • A direct connection with highly skilled team of scientists to discuss scientific challenges
  • A dedicated project team including R&D scientists to help ensure successful delivery of product to expectations

Resources

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