Featured Bioprocessing Editorial

1. Cleaning Process Capability: Understanding Populations, Samples, And Sample Size Requirements 6/6/2025

   This article examines the role of sample sizes in the determination of cleaning process capability or process performance in the manufacture of drugs/therapies and medical devices.

2. Demystifying The Common Technical Document For Global Submissions 6/5/2025

   The CTD's Module 3 is notoriously complex and challenging. Here are strategies for an easier path toward CMC submission readiness.

3. May 2025 — CDMO Opportunities And Threats Report 6/4/2025

   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.

4. The Matryoshka Model: The New Face Of Contract Packaging In Pharma 6/4/2025

   Contract packaging organizations are the outer layer of the pharmaceutical Matryoshka (the iconic Russian nesting doll): the final form that contains within it a series of intricately crafted parts.

5. Expanding A Bow Tie Risk Analysis Model Using Relational Risk Analysis 6/2/2025

   Relational risk analysis can be used to enhance and expand a bow tie analysis in the pharma and medical device industries to more effectively analyze risks as relationships between mechanisms and events.

6. The Latest On CRISPR Deployment In TIL Therapy Development 5/30/2025

   Here’s a quick look at how CRISPR’s emerging as an enhancer to improve TIL pharmacokinetics, efficacy, and tolerability without disrupting production.

7. Clues To Mapping A Crisis-Ready Tech Transfer Playbook 5/28/2025

   One of the many people behind AstraZeneca's COVID-19 response describes lessons learned during the biggest global health emergency of the modern era.

8. How To Automate Bioprocesses Without Locking Out Future Upgrades 5/28/2025

   Introducing automation now means you limit your ability to upgrade later. Early attention could give you options when the next generation of technology rolls around.

9. To Enhance Biotech Investments, Involve CDMOs Early In CMC Decisions 5/26/2025

   In Part 1, we introduced the critical link between CMC and prospective investors and/or licensees. Here we conclude with suggestions for how CDMOs can lend expertise early in discovery/development to improve the probability of securing investment or license for their clients.

10. Don't Miss These 2025–2026 EMA IDMP Compliance Deadlines For Product Management Services 5/22/2025

    The EMA's Product Management Services will serve as a comprehensive database for consistent identification of medicines internationally. One deadline is quickly approaching on May 31. Are you ready?