On the heels of Congress's reauthorization of the Prescription Drug User Fee Authorization Act, BridgeBio's chief regulatory affairs officer, Adora Ndu, explains the Commitment Letter, the programs that may be rolled, why right-sizing CBER will help the cell and gene sector going forward, and how sponsor companies can prepare for 2023 from a regulatory perspective. Listen now and subscribe so you never miss an episode!
For small biopharma businesses, it is nearly impossible to manage every aspect of the development process in house. Outsourcing provides the flexibility to change capacity and adjust timings.
Growing complexity and risks in drug development and supply have implications for outsourcing models. See how to structure and manage CDMO partnerships for a future filled with uncertainty and disruption.
This application note demonstrates a chromatography method for purifying reovirus RNA virus particles using a benchtop chromatography system, HiTrap brand columns, and Capto brand Core 700 resin.
Any changes to the equipment and processes used to produce a semi-solid dosage form may affect the physicochemical characteristics, bioavailability, and sensory qualities of the final product.
Cytopeutics, a provider of mesenchymal stem cells (MSC) for clinical trials and treatment, needed to conduct safety and tumorigenicity studies in appropriate animal models for its hMSC product.
Drs. Joachim Klein and Rebecca Michael from Lonza Pharma & Biotech answer attendee questions from a recent webinar about Lonza’s options for expressing and manufacturing complex biologic drugs.
Each of the diseases discussed is different in the way that they manifest is different, and the target cell arguably is going to be different as well. Straps and Kalayoglu break it down disease by disease.
