Featured Bioprocessing Editorial

1. Unlocking Method Insights For Novel Engineered AAV Capsids 9/18/2025

   Microfluidic platforms, such as labchip, are widely used for assessing wild type capsids. Now, engineered capsids are challenging these established workflows.

2. Why FDA's Tough Talk On Foreign Inspections Is More Bark, Less Bite 9/18/2025

   FDA Commissioner Marty Makary has promised to end the so-called "double standard" of announced overseas inspections. Does the agency have the resources?

3. Manufacturing Interleukin-2 For In Vivo Use: Key Considerations 9/16/2025

   Interleukins help optimize therapeutic outcomes in cancer immunotherapy and regenerative medicine. Manufacturing success requires stringent control over production, formulation, and stability to ensure safety and efficacy.

4. Sanofi's Digitalization Road Trip Shifts Into High Gear 9/16/2025

   The company's head of manufacturing discusses their latest investments in AI and automation, plus offers tips on how any company can start adopting advanced technology.

5. Why Pharmaceutical And Medical Device Risks Must Be Analyzed By Their Risk Mechanisms 9/16/2025

   Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad events. 

6. NanoCell's Moonshot Aims To Unlock In Vivo Cell Therapy 9/16/2025

   If the science holds, the implications include substantial cost reduction and putting engineered T cell therapies within reach of patients anywhere in the world.

7. 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.

8. 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.

9. 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.

10. 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.