Guest Columns
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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.
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Which Of These 6 Outsourcing Models Best Suits Your Program?
2/19/2025
Outsourcing used to be a cost-cutting exercise. Now drug developers use it to add expertise and manufacturing efficiencies to their production teams.
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Consumables Are Leading The Cleanroom Market — Here's Why
2/19/2025
As the industry expands, so, too does demand for PPE. This market analysis looks at the trends in consumables and other cleanroom technology used to make medicine.
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Comparison Of WFI Production Methods: Multi-Effect Distillation Vs. Vapor Compression
2/18/2025
The two most common hot water for injection (WFI) generation methods are multi-effect distillation (MED) and vapor compression (VC). There are significant differences in terms of operational principles and energy efficiency.
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Managing Contamination Risks In The Pharmaceutical And Medical Device Industries Using Relational Risk Analysis
2/18/2025
Of all the risks associated with pharmaceuticals and medical devices, controlling contamination is one of the most important and difficult challenges. Relational risk analysis (ReRA) can help.
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Growth And Trends In Topical Drug Contract Manufacturing
2/14/2025
Rising incidences of dermatological conditions, including acne, psoriasis, and skin cancer, are driving growth in topical drugs. Pharma companies are increasingly using contract manufacturers.
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Legend's CARVYKTI Offers Lessons In Commercial-Phase Changes
2/14/2025
The company is starting small with a pilot to do what most companies avoid altogether — innovating the manufacturing process for a product already on the market.
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FDA Issues Draft Guidance On The Use Of AI To Support Regulatory Decision-Making For Drug And Biological Products
2/14/2025
The U.S. FDA issued a draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. The public comment period ends April 7.
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Ensuring Repeatable, Viable Surface Sampling In Aseptic Settings
2/14/2025
Without high quality data, surface sampling simply becomes another exercise in checking regulatory compliance boxes.