Guest Columns

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. FDA Issues Draft Guidance On The Use Of AI To Support Regulatory Decision-Making For Drug And Biological Products 2/14/2025

    The U.S. FDA issued a draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025.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

  10. 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.