In the podcast series, Thermo Fisher Scientific’s Sr. Product Manager, Linas Pupelis, will discuss latest development of critical raw materials required to support the synthesis of mRNA for therapeutic development. Today, mRNA therapies are one of the hottest drug classes and the development of an entirely new drug class is not without challenges. A major issue in this industry is lack of high-quality raw material that meet clinical research and manufacturing regulations. In this podcast, we will discuss how our TheraPure reagents, which is specifically designed and carefully manufactured following the principles of 21 CFR 210/211 and ICH Q7, can help build the solutions to today’s challenges.
FDA's Francis R.W. Godwin (CDER) and Kathleen Jones, PhD (CBER) detail a record pace of drug warning letters and the CGMP deficiencies most commonly cited in biologics facility inspections.
Sanofi's Dr Jack Prior detailed a data maturity framework for biologics manufacturing, while FDA and Gilead panelists debated risk-based AI validation.
FDA's consumer safety officer, Jason Chancey, detailed real inspection findings, such as taped gaskets and delayed retesting, behind sterile facility deficiencies.
Regulatory approvals, trial data, and major licensing deals in 2026 are accelerating subcutaneous biologics, cutting patient burden and reshaping biopharma strategy.
Today’s biopharma news highlights GSK’s myeloma strategy, Insilico’s AI longevity research, and innovations that may improve future treatment outcomes.