Guest Columns

1. Blood Plasma Fractionation: Engineering And Facility Design For The Future Of Biotherapeutics 8/15/2025

   This article shares key considerations for bioprocessing facility design for plasma-derived medicinal products.

2. Navigating Contract Manufacturing Agreements: Tips And Pitfalls For Pharma And Biopharma Companies 8/13/2025

   When choosing the correct contract manufacturer, it is critical to negotiate a proper manufacturing agreement to define the relationship between all parties, allocate risks, and ensure all requirements are met with regard to legal, product specification, and IP matters.

3. How AI Is Revolutionizing Quality Management Systems 8/13/2025

   The real question isn't whether pharmaceutical companies should adopt AI in their quality systems, but how to implement it effectively and what specific benefits to expect.

4. Lean Manufacturing Implementation In Pharmaceutical Injectable Facilities 8/12/2025

   This comprehensive analysis examines lean manufacturing implementation challenges and evidence-based solutions derived from leading pharmaceutical organizations. 

5. July 2025 — CDMO Opportunities And Threats Report 8/11/2025

   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.

6. AI Meets CDMO: Smarter Outsourcing For Biologics And Cell And Gene Therapies 8/8/2025

   Vadim Klyushnichenko, Outsourced Pharma Board member and VP at California Institute for Biomedical Research (Calibr), continues his detailed discussion of utilizing AI at CDMOs to improve the outcomes for both sponsors and external service providers.

7. Inside Arbor Biotech's In Vivo Gene Therapy Approach 8/6/2025

   Following recent news about first-in-human testing, two executives discuss the science and manufacturing strategy for the company's lead candidate, ABO-101.

8. EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance 8/6/2025

   The EMA issued three new draft documents in July, all related to the advancement of the use of electronic technology in GMP: AI, computerized systems, and documentation. The public comment period ends Oct. 7.

9. Minimizing The Impact Of Human Errors Using Relational Risk Analysis 8/4/2025

   This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for minimizing the likelihood of a human error impacting pharmaceutical and medical device risks.

10. Trends And Benefits Of Lean Manufacturing In Pharmaceutical Injectable Facilities 8/4/2025

    The pharmaceutical injectable manufacturing sector is experiencing unprecedented transformation through lean manufacturing adoption. This analysis examines current implementation trends, productivity impacts, and quality integration strategies based on data from leading pharmaceutical organizations.