Editorial
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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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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 core 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.
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How Pharma 4.0 Can Unlock The Full Potential Of External Manufacturing
2/27/2024
To address today's challenges and other headwinds, pharma/biotech organizations and CMO/CDMO partners need to re-evaluate and improve externalized operating models. Consider further investing in digitalizing collaboration processes as part of operational excellence and digital transformation road map efforts.
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Risk And Supply Chain Continuity Management: Biologics Industry Perspectives
2/26/2024
We spoke to three long-standing members of BioPhorum’s Risk and Business Continuity Workstream about their companies’ approaches to risk management, supply chain continuity, and what they learned from the pandemic. Among them are Melinda McCants, senior resiliency officer at Amgen.
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Understanding And Navigating Diverse Regulatory Environments
2/21/2024
Drug developers aspire to treat patients globally, but navigating diverse regulatory structures around the world gets tricky. These consultants offer a primer on the regulatory bodies of the world.