Outsourced Pharma Editorial
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Doubling Down On Biopharma’s Growing Skills Drought
3/13/2024
The biopharmaceutical industry is building manufacturing capacity at breakneck speed. According to PhRMA, there are 1,580-and-counting biopharma manufacturing facilities in the U.S. alone. Problem is, we're way short on filling those facilities with skilled labor. NIIMBL wants to change that. Here's how, and a great opportunity for big pharma, biotech sponsors, CDMOs, academics, and more to help.
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A Structured Approach To Regulatory Information Management Vendor Selection
3/13/2024
Deploying a formal system for regulatory information management is a given now for all life sciences companies, irrespective of their size and focus. Regulators expect this, particularly as data rather than static documents evolves to become the default.
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Super Generics: Market Trends In Europe
3/12/2024
Super generics combine advanced formulations and delivery methods, and improved bioavailability, compared to traditional generics. This article shares market research trends in the market in Europe.
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What Investors Teach Us About CDMO Selection
3/12/2024
“My advice to a biotech when outsourcing to a CDMO is really understand what you want. I don’t mean this as a criticism, but selecting a CDMO is most often not within your circle of competence." Advice on overcoming that deficit from a successful biotech and CDMO investor.
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Getting To Know MAM, The New Quality Control Strategy On the Block
3/11/2024
When characterizing PQAs, the multi-attribute method offers a one-stop shop for analysis. This article explores technical considerations for this emerging strategy.
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Serial Success With Triumvira's Rob Williamson
3/10/2024
Rob Williamson's mind and hands have shaped more than 20 biotech startups, leading some to IPO and landing others firmly in Big Bio through acquisition by companies like Merck. Hanging around as many successful exits as Williamson has seen, one might become an expert via osmosis. But Williamson isn't passive about honing his vision for progressive therapeutic dealmaking.
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What Proposed Plasmid DNA Standards Say For GMP/Non-GMP Production
3/8/2024
Today’s standards for plasmid DNA production lack specificity, and manufacturers have been clamoring for more. In late 2023, USP published draft General Chapter <1040> to help fill in the cracks.
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Navigating China's Biologics Approval And Accelerated Pathways
3/8/2024
Pharma companies doing business in China have four key routes to register drugs faster than the standard ways. This discussion breaks down accelerated pathways and offers tips on how to approach them.
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Process Development: Stuck In The Middle With You
3/8/2024
There is pressure to accelerate programs out of research, and into development. Then, despite the complexity of new drugs, therapies and technologies, process development chemists are asked to quick-step to clinical grade, and commercial-ready material. For their part, CDMOs need to react to it all.
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Drugging The Undruggable: Strategies And Future Directions
3/7/2024
Progress with PROTACs and molecular glues hasn’t come without challenges, particularly in identifying the right chemistry starting point for drug development — a process known as hit discovery. This article looks at the role of CRISPR, screening assays, and more.