Expert Insights On Downstream Bioprocessing

  1. A Practical Look At Modern Downstream Processing For Biologics 2/25/2026

    Part 2 in a series about current bioprocessing practices explores the latest in separation, purification, sterile filtration and aseptic filling.

  2. 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.

  3. Leveraging Conventional Therapeutics Skills For Cell And Gene Therapy 2/6/2026

    Cell and gene therapies share fundamental objectives with conventional biologics. Their common challenges offer a natural starting point to solving downstream bottlenecks.

  4. Why Use Total Organic Carbon Analysis For Cleaning Validation? 1/21/2026

    Total organic carbon analysis is probably the most “fit for use” analytical method to validate cleaning processes, particularly within a science- and risk-based approach.

  5. Survey: SUS Insufficient For 40% Of Biopharma 12/30/2025

    New data from BioPlan Associates suggests single-use systems adoption may be plateauing with single-digit growth rates.

  6. TFF Offers Ideal Anaerobic, GMP Conditions For LBP Concentration 12/8/2025

    When configured correctly, TFF provides the gentle processing environment and oxygen protection required for strict anaerobes.

  7. Strained Manufacturing, Complexity Stymie In Vivo Progress 12/4/2025

     Explicitly mapping delivery challenges to the associated GMP process steps converts biological risk into operational risk.

  8. Dual Membrane Preconditioning Can Improve Concentration, Cut HCPs 10/27/2025

    Research from Penn State, the FDA, and Takeda shows how combination filtration and purification steps improve output and reduce impurities.

  9. Pfizer's Accord For A Healthier World Program Challenges Stability Study Norms 10/22/2025

    The company developed a novel approach to address the historic lack of stability testing for underserved parts of the world, near the equator.

  10. Survey: 30% Of Biopharmas Cite Cost, Productivity As Top Priorities 10/6/2025

    Both focus areas aim at the same outcome, stronger economics and sustainable competitiveness, according to BioPlan Associates' 22nd Annual Biomanufacturing Report.