Featured Bioprocessing Editorial

1. The EU Overhauls Pharma Laws: What You Need To Know 11/2/2026

   On Sept. 18, the Council of the EU published the almost-final text of a major overhaul of the EU pharmaceutical laws. The final binding text is expected to be published very soon.

2. Can Peptide Mapping Predict Intact Antibody PTM Distributions? 11/2/2026

   Peptide mapping quantifies modification at individual sites, but the same site-level results can correspond to different distributions across intact molecules.

3. Closing The CAR-T Access Gap With Hospital-Based Manufacturing 10/30/2026

   Improvements in closed-loop processing and lower material costs could bring distributed manufacturing within reach. Hospitals still need to stand up production suites.

4. How To Stand Up A Hospital-Based CAR-T Manufacturing Network 10/30/2026

   Estimates show that a small hospital-based, modular GMP facility can deliver more than 250 products per year with more flexibility than fully automated, integrated equipment.

5. September 2026 — CDMO Opportunities And Threats Report 10/28/2026

   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.

6. An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs? 10/28/2026

   FDA’s real-time CRL releases face legal and operational hurdles. Could AI-assisted redaction make transparency faster and more consistent?

7. Navigating Outsourced Pharmaceutical Testing Through Today's Geopolitical Uncertainty 10/22/2026

   Geopolitical shocks are reshaping outsourced pharmaceutical testing. Learn how procurement teams can strengthen resilience and protect continuity.

8. 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.

9. 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.

10. 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.