Guest Columns

1. The Regulatory Imperative To Improve Environmental And Sustainability Stewardship In Biopharma 9/15/2025

   As the industry faces increasing pressure to align with environmental, social, and governance (ESG) standards, companies must evaluate how to integrate supply chain management with these initiatives to drive sustainability and mitigate risks.

2. How You And Your CDMO Should Leverage Contamination Control Strategies For Competitive Advantage 9/15/2025

   It is no longer sufficient to just meet compliance requirements; a proactive, risk-based approach to contamination control is now a differentiating factor that enhances operational efficiency and more. For biotech companies evaluating CDMOs, this shift is critical.

3. Leveraging AI And Data Science For Biologics Characterization 9/12/2025

   Modern analytical tools produce more data than we know what do with. Artificial intelligence helps condense, interpret, and utilize what's most meaningful.

4. Operating And Maintaining Pharmaceutical Gas Distribution Systems 9/12/2025

   Drug manufacturers face stringent requirements when using gas that comes into direct contact with the product. This guide discusses operation, maintenance, and monitoring of gas systems.

5. August 2025 — CDMO Opportunities And Threats Report 9/11/2025

   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. What Biotech Sponsors Should Look For In A CDMO For Sterile Fill/Finish 9/11/2025

   Choosing the right CDMO partner for a biotech product isn’t about “capacity at a good price”; it’s about a partner with the right mix of technical expertise, regulatory track record, and more.

7. How AbbVie's Digital Transformation Brought Platform Knowledge Closer 9/9/2025

   A custom-built digital ecosystem reduced the time spent on documentation in AbbVie's bioprocess development labs by about 70% for some experiment types.

8. The New FDA Era Of Radical Transparency And Pervasive Oversight 9/9/2025

   The first half of 2025 has been transformative for biopharmaceutical quality and regulatory affairs, with the FDA leading the charge with four significant changes. Curadian Group's David Grote discusses implications for all four.

9. A Case Study In Continuous Process Verification 9/8/2025

   CPV can strengthen the bridge between compliance and continuous improvement. In this scenario, a hypothetical lab sets out to improve process yields and efficiency.

10. Optimizing Lentiviral Vectors For Allogeneic CAR-T Manufacturing 9/5/2025

    A group of graduate researchers explored VSV-G affinity chromatography as an alternative to the standard anion exchange chromatography or AEX.