Featured Editorial

1. Tales From The Trenches: Developing Potency Assays Outside Big Pharma 7/18/2025

   Lessons learned from developing potency assays to detect activity and variation for cell- and receptor-mediated products — beyond the comforts of a well-heeled company.

2. FDA Quietly Eases Nitrosamine Reporting Rules Ahead Of August Deadline 7/17/2025

   The FDA changed expectations for nitrosamine drug substance-related impurities reporting, accepting progress reports in lieu of full compliance. Here's what it means.

3. Is Your Pharma Facility Ready For The Next Public Health Crisis? 7/17/2025

   Preventive measures wane as a sense of security resumes. Follow these tips to protect business continuity in the next global health crisis.

4. FDA Leading The Decline Of Animal Testing 7/16/2025

   The gold standard practice of conducting animal studies for evaluating toxicity, pharmacodynamics, and immunogenicity is being challenged by innovative alternatives – New Approach Methods (NAMs).

5. A Flexible Mindset For Bridging Between Cell-Based Assay Groups 7/16/2025

   Transferring cell-based assays for biologics starts with defining operator and equipment parameters, positive and negative controls, and a sufficient dynamic range.

6. Advanced Manufacturing And CDMOs Are Rewriting The CGT Cost Equation 7/16/2025

   Without contract manufacturers, small biotechs often don't stand a chance of reaching commercial production scales, let alone global access for their drugs.

7. Exploring Outsourcing's Role In CGT Scalability And Affordability 7/16/2025

   CDMOs give therapy developers access to state-of-the-art production platforms and expertise without the massive up-front investment required for in-house manufacturing.

8. 4 Centralized Comparator Sourcing Models To Fortify Supply Chains 7/15/2025

   A team at Novartis developed models to address the often-overlooked challenge of clinical trial comparator sourcing, a weak link that can derail trials.

9. Governor Josh Shapiro On Supporting Biomanufacturing In Pennsylvania 7/15/2025

   Bioprocess Online's coverage of Governor Josh Shapiro’s fireside chat with BIO CEO, John Crowley, at the 2025 BIO International Convention.

10. Essential Steps For A Successful Analytical Tech Transfer 7/14/2025

    Biologics tech transfer means sharing up to 20 assays. Miss a step, and you risk delays, bad data, and products stuck in limbo.