Scaling up manufacturing when it’s needed most

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

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

Breaking new ground on animal origin-free reagents

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

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

CMD SchemaApp code