Guest Columns

1. Incorporating AI Tools Into Downstream Process Optimization 5/8/2025

   Data-driven, hybrid modeling complements mechanistic thinking by reducing computational load for faster decision-making when time is a critical consideration.

2. A Road Map For PAT Monitoring And Control 5/8/2025

   Process analytic technology monitoring and control is rapidly progressing. BioPhorum shares new best practices on how to move from concept through life cycle management and/or regulatory approval of the PAT application.

3. Hard Lessons In Parenteral Automatic Visual Inspection 5/7/2025

   Complex problems can have simple solutions. That's what a team at AstraZeneca found when they set out to reduce false rejection rates in vials containing mAbs.

4. From Preparation To Compliance: DSCSA Implementation Takes Big Steps In 2025 5/7/2025

   The phased exemption periods of the Drug Supply Chain Security Act (DSCSA) expire on different dates throughout 2025 (including one quickly approaching in May), marking a series of milestones for implementation.

5. Addressing Human "Error" In Pharma Manufacturing 5/7/2025

   Why is it that managers at pharma manufacturing sites continue to be frustrated by what could be labeled as “avoidable” human errors, and what can companies do about it? Let's investigate.

6. Proper Care And Handling Of Coupons Used For Swab And Rinse Recovery Studies For Total Organic Carbon Analysis 5/6/2025

   Surrogate surfaces, or “coupons”, are used to simulate pharmaceutical manufacturing surfaces or medical devices for the performance of swab and rinse recovery studies. Experts from The Center for Pharmaceutical Cleaning Innovation provide insights for proper care and handling.

7. EMA Issues Draft Reflection Paper On Accelerating Biosimilar Approval 5/5/2025

   In April, the European Medicines Agency issued a draft of a new guidance document titled Reflection paper on a tailored clinical approach in biosimilar development. The public consultation runs until Sept. 30, 2025.

8. 8 Ways To Drive Resilience In Oncology Drug Supply Chains 5/2/2025

   From traditional chemotherapy to advanced immunotherapies and nanotechnology, pharma/biotech companies must overcome logistical hurdles that affect their oncology products' availability and quality.

9. Using Virtual Reality To Enhance Aseptic Contamination Control 5/1/2025

   Technologies such as virtual reality (VR), augmented reality (AR), or mixed reality can help alleviate some of the long-standing issues in aseptic contamination control. Here's how.

10. Lean Thinking For Pharma — Flow Without Facility Upheaval 4/28/2025

    Lean offers manufacturers a host of efficiencies, but they don't all work for GMP. Here are some ideas for translating best practices for a highly-regulated industry.