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A conversation with Linda Pissott Reig, REMS Industry Consortium | The FDA recently asked for comments about how the government handles vendor change requests from drug sponsors with risk evaluation and mitigation strategies. So, we asked a REMS expert to help us understand why the agency is focusing on the broad-reaching program and what it could mean for drug manufacturers with REMS products in their portfolios. |
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From his vantage point as an independent biotech journalist, Luke Timmerman has been watching the expansions and retractions of the industry for a couple of decades now. His unique perspective is hard to equal, and that perspective is, despite tough markets and tepid public sentiment, decidedly bullish. |
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| Determining Thermal Stability Of Antibodies With A Nano DSC | Application Note | TA Instruments | Explore the performance of an instrument with data analysis software capabilities that easily deconvolutes thermograms, enables differentiation between individual and interacting domains, and reports accurate Tm values. |
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| Customer-Supplier Collaboration Overcomes Supply Chain Limitations | Article | By Brian Crawford, Asahi Kasei Bioprocess | Better understanding the root cause of a supply chain issue helps set more realistic timelines for customers and generates more collaborative problem-solving efforts between drug manufacturers and their suppliers. |
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| Delivering Genetic Editing Therapies To Market | Article | By Dr. Rajiv Vaidya and Dr. Samir Acharya, Andelyn Biosciences | Manufacturers with proven expertise in areas such as viral vector production and analytics are needed now more than ever to get breakthrough, deliverable gene editing therapies to patients. |
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| Benefits Of RABS, Isolator Tech In A Changing Regulatory Landscape | Article | By Ryan Rivers, Shane Mohr, and Lisa DeOerio, Emergent CDMO | Restricted access barrier systems or isolator technologies are an integral component of quality control. Understanding the key elements of each ensures the most informed decision for your product. |
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| The Promise Of PCM: Getting To Maturity | White Paper | By Bikash Chatterjee, Pharmatech Associates - A USP Company | PCM offers several advantages, including streamlined development and increased flexibility. Review the key drivers for PCM as well as the hurdles that stand in the way of industrywide adoption. |
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| Simplify The Qualification Of Your GMP Proteins With Maurice | Application Note | bio-techne | Discover a fast, easy, and streamlined method for characterizing the identity and purity of commonly used GMP cytokines in immune cell therapy manufacturing using an automated capillary electrophoresis instrument. |
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| Join Bioprocess Online Live for a discussion on two approaches to adoption of computational technology — do-it-yourself and outsourcing. Whether you're considering how AI and ML can increase drug discovery, design, and development efficiencies, dabbling in it already, or leading the charge, you won't want to miss this conversation from the edge of what's possible. Registration is free thanks to the support of Cytiva. Register now |
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Check it out today for access to candid interviews with top-tier executives on how they do business. |
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