Bio Most Popular

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. Preparing For FDA's Expanded Use Of Unannounced Inspections At Foreign Manufacturing Facilities 7/10/2025

   The FDA announced on May 6, 2025, that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. Here are key considerations and actions to take in order to be prepared.

7. Managing Extractables And Leachables In HPAPI Manufacturing 7/10/2025

   These contaminants can compromise the quality, stability, and safety of a drug product, and regulatory bodies mandate assessment to protect patients.

8. Drug Facility Design For Live Biotherapeutic Products 7/8/2025

   Live biotherapeutic products use live microorganisms or yeast as active agents to prevent or treat diseases. For pharma manufacturers entering this emerging field, understanding the unique GMP requirements is critical.

9. June 2025 — CDMO Opportunities And Threats Report 7/3/2025

   Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

10. 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.