BIO From The Editor and Guest Columns
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2024 LIMS Trends
3/15/2024
The laboratory information management system (LIMS) landscape in 2024 is a dynamic one, driven by accelerating advancements in technology and evolving industry needs. This article shares the four key trends.
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A New Model Approach To Drug Shortage Prevention
3/15/2024
The ISPE's Drug Shortages Prevention Model revamps its predecessor, the more prescriptive Drug Shortages Prevention Plan, with a focus on 12 key performance areas.
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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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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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Debra Weiss, RN: Big Impact In Small, Non-Profit Bio
3/8/2024
The career of Debra Weiss, RN, MSN, and COO at the biopharma Gates Medical Research Institute (Gates MRI), offers a case study in creating success through service-oriented leadership.
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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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Shocking! Biotech Facilities Don't Maintain Themselves
3/4/2024
Don't get trapped in the misconception that only biomanufacturing process systems need maintenance. Here are some real-life examples of facility maintenance programs gone wrong.