Expert Insights On Upstream Bioprocessing

  1. Sorriso's Path To Oral Biologics Dosing Is Through The Gut 6/30/2025

    Following positive results from a Phase 1b trial, company leaders describe scaling their yeast expression and spray-drying processes as they prepare for Phase 2.

  2. Closed-Loop Manufacturing Is The Cell Therapy Revolution We Need 6/18/2025

    In cell therapy manufacturing, automated closed systems with integrated software controls offer numerous benefits over traditional open systems.

  3. The Promise And Challenges Of Cell-Free Protein Systems 6/10/2025

    CFPS use cell lysates or purified enzymes to synthesize proteins. They have emerged as a promising alternative to production with living cells.

  4. 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.

  5. Is Early Automation The Key To Scalable Cell Therapy Manufacturing? 5/8/2025

    Picking which phase to introduce automation has serious implications, and the calculation is unique for every product. Here are some important considerations.

  6. Proper Care And Handling Of Coupons Used For Swab And Rinse Recovery Studies For Total Organic Carbon Analysis 5/6/2025

    Surrogate surfaces, or “coupons”, are used to simulate pharmaceutical manufacturing surfaces or medical devices for the performance of swab and rinse recovery studies. Experts from The Center for Pharmaceutical Cleaning Innovation provide insights for proper care and handling.

  7. Do We Really Understand Plasmid Quality's Effects On mRNA Production? 5/1/2025

    Two experts examine the current guidelines and specs for plasmid DNA and question whether our understanding is sufficient.

  8. Common Manufacturing Challenges For LBP Formulations 4/23/2025

    As more companies explore live biotherapeutic products, ensuring stability is likely to be front and center with unique challenges for oral and topical applications.

  9. How CAR-NKs Offer Powerful Therapeutic Flexibility 4/15/2025

    Induced pluripotent stem cells have emerged as a promising platform for producing CAR-engineered NK cells in a standardized, renewable, and scalable way.

  10. Ramping Up GMP-Compliant CAR-NK Manufacturing At Scale With iPSCs 4/15/2025

    The ability to produce billions of NK cells in a single production run represents a transformative shift in the economics and logistics of cell therapy.