BIO From The Editor and Guest Columns
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What FDA Draft Guidance Tells Us About In-Process Control Strategies
2/28/2025
The draft aims to modernize the regulations in 21 CFR 211.110 catching up to progress in the field including advanced manufacturing and analytical technologies.
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Areas For Advancement In Peptide Manufacturing
2/27/2025
Experts from Eli Lilly, NervGen, and Piramal Pharma Solutions discuss the myriad of ways peptide manufacturing can be improved, drawing on years of industry experience and insight.
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Pharma 4.0 Adoption Needs Cooperation — Here's How To Build It
2/27/2025
A recent survey by the International Society for Pharmaceutical Engineering found that an inadequate company culture raised the greatest barrier to digital maturity.
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Deciphering FDA's 7-Step Framework For AI-Driven Decision-Making
2/27/2025
The draft framework, published in January, aims to ensure that AI systems used in drug development are robust, reliable, and aligned with regulatory expectations.
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How To Optimize Downstream Separation With Tagless Proteins
2/26/2025
The intein-based magnetic bead system enables effective affinity capture, tag removal, and buffer exchange, supporting direct analytical applications.
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Strengthening Shop-Floor QA From The Ground Up
2/24/2025
Quality is created where and when manufacturing happens, not later through inspection. This approach integrates the QA function into daily production operations.
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9 Reasons Why You Should Consider AI In Analytical Instrument Qualification
2/21/2025
AI is about to completely change the analytical instrument qualification (AIQ) landscape in the pharma/biopharma and medical device industries.
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10 Ways To Speed Up CMC In Early-Stage Drug Product Development
2/21/2025
The inherent complexity of living cell-based products, vector-based gene therapies, and highly sensitive analytical methods demands robust change management strategies.
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ADC Manufacturing's Biggest CMC Challenges And Ways To Approach Them
2/19/2025
Manufacturing ADCs is inherently more complex than other biologic drug products. Let's explore some of the key issues, including aggregation, solubility, and thermal instability.
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Challenges And Opportunities Of Outsourcing Biopharma Development
2/19/2025
Oversight, knowledge management, and operational/compliance risk make up the three key challenge classifications to consider when approaching a new outsourcing agreement.