GUEST COLUMNISTS

• Challenges And Opportunities Of Outsourcing Biopharma Development

  Oversight, knowledge management, and operational/compliance risk make up the three key challenge classifications to consider when approaching a new outsourcing agreement.

• Consumables Are Leading The Cleanroom Market — Here's Why

  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.

• Comparison Of WFI Production Methods: Multi-Effect Distillation Vs. Vapor Compression

  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.

• Managing Contamination Risks In The Pharmaceutical And Medical Device Industries Using Relational Risk Analysis

  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.

• FDA Issues Draft Guidance On The Use Of AI To Support Regulatory Decision-Making For Drug And Biological Products

  The U.S. FDA issued a draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025.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.

• Ensuring Repeatable, Viable Surface Sampling In Aseptic Settings

  Without high quality data, surface sampling simply becomes another exercise in checking regulatory compliance boxes.

• Emerging Trends In mAbs Manufacturing In 2025 And Beyond

  Two key innovations — continuous perfusion in upstream processing and multicolumn chromatography in downstream processing — are having a profound impact on biologics manufacturing.