Guest Columns
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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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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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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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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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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.
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8 Key Takeaways Of The Proposed FDA Modernization Act 3.0
3/6/2024
On Feb. 6, 2024, new legislation was introduced in the House of Representatives: the FDA Modernization Act 3.0. It aims to reduce and replace the use of animals in nonclinical research, improve predictivity of nonclinical testing, and potentially reduce drug development times. This article shares an overview. Note that the proposed legislation would still need to go through its course of passing the House and Senate and being signed by the president before becoming a law.
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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.
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Green Gains In Biopharma Without Closing Facilities?
2/29/2024
Going green is virtually impossible for biopharma companies with legacy systems, but going greener might be within reach. Here are some ideas to get started.