Featured Editorial

1. Is Your Supply Chain Ready For The End Of Class VI? 10/21/2026

   Revisions to USP <87> and <88> update biological reactivity testing — changes that are especially important for companies that rely on single-use technology.

2. On The Ground At BPI: Tatyana Matveeva, Ph.D., On Distributed Manufacturing Models 10/16/2026

   Bioprocess Online caught up with Tatyana Matveeva, Ph.D., at the 2026 BioProcess International conference to discuss her panel session on distributed manufacturing.

3. When Lyophilization Fails At Scale, First Scrutinize Your Formulation 10/16/2026

   When lyophilizing a challenging biologic drug product, use an integrated approach optimizing formulation and process parameters together.

4. Contextualizing Data To Enable AI And Prevent Knowledge Leaks 10/15/2026

   Bioprocess Online's Tyler Menichiello interviews Martin Kockx, a principal manufacturing systems engineer at Vertex Pharmaceuticals, on his presentation at 2026 BPI, “Transforming Biomanufacturing: Why Architecture Must Precede Analytics."

5. The 5 Shifts That Could Remake Lyophilization By 2040 10/15/2026

   Purdue University-based LyoHUB charts a risk-based course to modernizing freeze-drying technology for better performance and advanced modalities.

6. On The Ground At BPI: Jacqualyn Schulman, Ph.D., On Accelerating Clonal CLD 10/9/2026

   An interview with Jacqualyn Schulman, Ph.D., a principal scientist at Bristol Myers Squibb (BMS), on her presentation at BPI 2026, “Fast-Tracking CHO Cell Line Development Using Integrated Engineering Strategies.”

7. Complete Response Letters For CGTs Share This Common Theme 10/7/2026

   One expert’s analysis found CMC-related concerns in about 75% of complete response letters. He outlines a path to stronger CMC readiness for cell and gene therapies.

8. Your 7 Decisions To Make Before MES Configuration 10/7/2026

   Don't wait until manufacturing execution system (MES) configuration to answer these 7 questions. Define your manufacturing process before digitizing it.

9. DEA Reveals Hidden Costs Of Analytical Validation Guidelines 10/2/2026

   By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.

10. Qualification And Validation Of Depyrogenation Tunnels And Autoclaves 10/2/2026

    Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization.