6.1.1 The regulatory landscape for mRNA therapeutics and vaccines is undergoing significant discussion within the industry and is expected to evolve going forward. One key question has to do with whether mRNA products should be considered gene therapies.
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6.2.1 Therapeutics are classified as a biologic based on how they are manufactured. For this reason, mRNA and any other RNA made by in vitro transcription (IVT) are considered biologics and therefore regulated by CBER. CBER was created to regulate therapies that are produced by biological processes and therefore known to have complex drug substance profiles. An antibody therapeutic, for example, will have numerous glycosylation isoforms in addition to a low level of chemical modification to the residues, such as oxidation and deamidation. CBER has established a regulatory strategy to evaluate these therapies for safety and efficacy, while allowing for variation within the therapeutic.
Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.