Expert Insights On Downstream Bioprocessing

1. All The Ways Global Biopharma Still Grapples With Annex 1 3/19/2026

   Biopharma companies can't consistently meet Annex 1 expectations. At the heart of the problems, regulators have shifted the burden of proof to manufacturers.

2. Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables 3/17/2026

   A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.

3. New MIT Consortium Links Innovation With Real-World Biomanufacturing 3/6/2026

   In one area, the Initiative for New Manufacturing is exploring whether microfactories, championed by the EV industry, can help biopharma iterate facility design faster.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.