Guest Columns
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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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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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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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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.