Guest Columns

1. Cleaning Process Capability: Risk-Based Cleaning Process Performance Qualification 7/1/2025

   A cleaning validation professional must know how many process performance qualification runs are necessary. Here's how to go about demonstrating this with a high degree of assurance while minimizing the number of qualification runs.

2. Sorriso's Path To Oral Biologics Dosing Is Through The Gut 6/30/2025

   Following positive results from a Phase 1b trial, company leaders describe scaling their yeast expression and spray-drying processes as they prepare for Phase 2.

3. Why 'Which Is Best?' Is The Wrong Question In CGT Development 6/27/2025

   In cell therapy development, the instinct to seek a single “best” option is natural — but in reality, there’s rarely a universal winner.

4. Understanding FDA's New National Priority Voucher Pilot Program 6/25/2025

   The FDA's vouchers will be issued to companies addressing health issues in the U.S. and increasing domestic manufacturing, among other criteria.

5. The Latest Techniques And Technology For Differentiating Capsids 6/24/2025

   Since AAV gene therapy’s origins, scientists and regulators have sought optimized ways to measure empty/full capsids. This expert reviews pros and cons of modern methods.

6. Smarter CDMO Engagement with AI In Biologics And Cell & Gene Therapy 6/24/2025

   In biologics and cell and gene therapy (CGT), selecting and managing a CDMO has become a strategic imperative. Unfortunately, traditional approaches to external partners can fall short. But now AI is reshaping this landscape. Analysis from an Outsourced Pharma Board member.

7. AI-Assisted QMS: Bridging ISO/IEC 42001:2023 And ICH Q10 For Pharmaceutical Excellence 6/23/2025

   Integrating AI into quality management systems (QMS) can be a transformative opportunity to enhance quality assurance, improve compliance, and enable proactive risk management. 

8. Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future Oversight 6/23/2025

   Recent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political and economic pressures. Here are the newest developments and emerging focal points.

9. Ask The Pros — The Latest In Downstream HCP Mitigation 6/20/2025

   Two downstream biologics processing experts address some of the field's complex, nagging questions about mitigating host cell proteins.

10. Understanding FDA's Draft Guidance: Composition Statements Of Ingredients In Labeling In NDAs And ANDAs 6/20/2025

    The FDA's 2024 draft guidance details presentation of a drug product’s composition and the corresponding details of the ingredients in the product labels for NDAs and ANDAs.