For companies looking to bring mRNA therapeutics and vaccines to market, TriLink’s proprietary GMP-grade CleanCap® reagents offer an immediate solution for swiftly scaling from clinical to commercial. CleanCap technology is the fastest and easiest way to produce a 5’ Cap1 mRNA with 95% efficiency. GMP CleanCap reagents are a modern alternative to enzymatic capping and are ready to accelerate your mRNA therapeutic development. In this podcast, we will discuss how TriLink discovered this mRNA capping method and how they made it scalable to support global vaccine supply, as a key raw material for over 3 billion vaccines doses against COVID-19.
The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits in roughly 70% of small-molecule pipelines.
Lori Dingledine, QC Director Microbiological Control and GTIC Operations at Genentech, provided input on the regulations surrounding raw material manufacturing and use for ATMPs in a presentation at the 2026 PDA/FDA Joint Regulatory Conference.
FDA opens applications for its Expedited IND Pilot, pairing sponsors with qualified research institutions to test rolling CMC review ahead of first-in-human trials.
2026 approvals, clinical data, and licensing deals are advancing subcutaneous biologics, reducing patient burden, and reshaping biopharma drug strategy.
At the PDA/FDA Joint Regulatory Conference 2026, Helen Motamen, MS
global head, Sanofi Quality Audit, Inspection, Intelligence & Advocacy, at Sanofi, provided advice for creating a strong internal audit program.