GUEST COLUMNISTS

• Cleaning Process Capability: Risk-Based Cleaning Process Performance Qualification

  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.

• Sorriso's Path To Oral Biologics Dosing Is Through The Gut

  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.

• Why 'Which Is Best?' Is The Wrong Question In CGT Development

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

• Understanding FDA's New National Priority Voucher Pilot Program

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

• The Latest Techniques And Technology For Differentiating Capsids

  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.

• Smarter CDMO Engagement with AI In Biologics And Cell & Gene Therapy

  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.

• AI-Assisted QMS: Bridging ISO/IEC 42001:2023 And ICH Q10 For Pharmaceutical Excellence

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

• Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future Oversight

  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.