0:00ThermoFisher
0:00SCIENTIFIC
0:00Guidebook on selecting
0:00mRNA raw materials
0:00Achieving consistency in
0:00process development of
0:00mRNA therapeutics:
0:00The importance of raw materials
0:00Sponsored by
0:00BIOPHARMA DIVE
0:00Content created by Studio ID
0:02Why quality and
0:02documentation matter
0:02Why raw
0:02materials matter
0:02What are the consequences of selecting suboptimal materials?
0:02The SARS-CoV-2 crisis, and the prophylactic mRNA
0:02vaccines it spawned, brought mRNA to the forefront as an exciting new frontier in medicine.
0:02The global pandemic accelerated mRNA research and developmen
0:02and manufacturing at an unprecedented rate. In March 2021,
0:02Pfizer and BioNTech, and Moderna, announced that they were
0:02on track to manufacture 2.5 billion and 1.4 billion doses,
0:02respectively, of their COVID-19 vaccines by the end of 2021.
0:02Developers now recognize that the success of mRNA therapeutics
0:02in the clinical and commercial settings depends heavily on the
0:02quality of the raw materials used to manufacture them.
0:02The rapid rollout of mRNA vaccines is an
0:02unprecedented feat of science, showcasing the
0:02immense potential of mRNA therapeutics. However,
0:02the process development of mRNA therapeutics is
0:02still relatively new, and there is an ongoing
0:02challenge to ensure product quality from the
0:02raw material stage.
0:05Tips on evaluating
0:05materials and suppliers
0:05Reliable, consistent
0:05materials are key
0:05Achieving consistency
0:05begins with quality control
0:05Validated vs. verified: a glance
0:07Achieve consistency in
0:07process development
0:07How to select the optimal
0:07raw materials for consistency
0:07Five questions to ask as you evaluate
0:07materials and suppliers:
0:07Does the supplier offer product
0:07quality assurance (QA) materials with
0:07documentation to support its claims?
0:07Any these materials appropriate
0:07for the development and
0:07manufacturing of a therapeutic?
0:07Spotlight on enzyme
0:07quality support
