Biomanufacturing Featured Articles

1. Drug-Device Combination Products: 4 Evolving Platforms For 2026 4/10/2026

   Biologic advantage won’t come from better biology alone, but from delivery technology and designing the full experience around patients, providers, and supply chains.

2. Integrate Upstream/Downstream To Reduce Development Risks And Costs 4/8/2026

   Coordinating unit operations can help reduce costs and mitigate challenges in process development. Check out these key takeaways from the Bioprocess Online Live event “Optimizing Process Development Through Upstream and Downstream Integration.”

3. From IV To Subcutaneous: It's Not About Convenience, It's About System Design 4/6/2026

   IV→SC transition extends beyond dose, volume, concentration, and device; it requires integrated system design, not a series of isolated optimizations.

4. Evaluating Mass Spectrometry Methods For Host Cell Protein Quantification 3/26/2026

   New USP 1132.1 guidelines standardize mass spectrometry for host cell protein analysis. These methods provide the specific protein identification and quantification needed to reduce clinical risk.

5. How Drugs Are Manufactured And Administered 3/16/2026

   Modern medicine includes far more than familiar over‑the‑counter products. Explore how drug composition, formulation, and administration work together to shape today’s therapies.

6. Scaling MSC Therapies: Overcoming Cell Therapy Manufacturing Risks And Barriers 2/26/2026

   Achieve scalable MSC manufacturing by implementing closed systems and modular scale-out strategies that minimize contamination risks and ensure consistent cellular stability and efficacy.

7. Clearing The Path To Approval: Residual Reagent Control In AAV Gene Therapy 2/22/2026

   Stricter regulatory expectations for AAV therapies demand robust control of residual transfection reagents, comprehensive documentation, and proactive quality strategies to avoid costly development delays.

8. A Novel In Vitro Glycosylation Approach For Difficult PTMs 2/19/2026

   Post-translational modifications of membrane proteins have been historically challenging. Research shows how an in vitro approach brings stability and predictability.

9. Active Versus Passive Shipping Solutions For Clinical Shipments 2/13/2026

   Explore active and passive temperature-controlled shipping solutions and their impact on clinical trial supply, balancing cost, risk, and product integrity.

10. Lyophilization: Protecting And Preserving Biologics 2/4/2026

    Discover how lyophilization revolutionizes biologic drug manufacturing and ensures potent, stable treatments for complex diseases.