Regulatory

31. Levers For Streamlining And Optimizing The Biosimilar Process 4/20/2026

    New and more advanced production methods mean biosimilar developers can produce their own versions of commercial drugs with greater efficiency. Levers like cell line engineering and bioreactor controls make it easier to increase productivity. Biologics Consulting Group Principal Consultant Vince Narbut walked through some of the unit operations ripe for optimizing during Bioprocess Online Live: Process Control's Increasing Role In Biosimilar Approval.

32. Flexibility First: A Fill And Finish Collaboration Story 1/7/2026

    Learn how Annex 1 is influencing isolator strategies, why standardization is key to efficiency, and how collaboration can simplify integration for reliable drug product filling.

33. Engineering Bacterial Vector-Based Immunotherapies With OS Therapies' Paul Romness and Robert Petit, Ph.D. 10/7/2025

    In this episode of “Better Biopharma,” host Tyler Menichiello is joined by OS Therapies’ CEO, Paul Romness, and chief medical and scientific officer, Robert Petit, Ph.D. The three discuss the development and manufacturing of the company’s lead asset, OST-HER2, a Listeria-based immunotherapy for osteosarcoma.

34. Facing NASH Therapeutic Skepticism With 89bio's Rohan Palekar 8/9/2023

    The non-alcoholic steatohepatitis (NASH) therapeutics market has proven to be an 11/10 on the difficulty scale. Despite billions of big biopharma dollars invested in therapeutic development, and a few close calls, no therapeutics has yet reached the finish line.

35. The ICH Q5A Revision, Its New Scope And Guidance 12/1/2022

    Learn about the ICH Q5A revision addressing viral safety of biotechnology products derived from cell lines of human or animal origin that was recently published for public comment.

36. Dr. Peter Marks Talks a Standardized Playbook for Gene Therapy Manufacturing 1/30/2024

    In this segment, Dr. Peter Marks shares developments in CMC for advanced therapies in the near future.

37. MilliporeSigma Bio-Expo Live February 2025: Upstream Bioprocessing 3/18/2025

    Review the benefits of implementing a closed and sterile sampling system, such as NovaSeptum®, to improve sampling procedures and meet regulatory expectations.

38. Streamline Production With A Final Filling Single-Use Set 8/7/2025

    Streamline your production with a Final Filling Single-Use Set that installs in under 10 minutes to eliminate cleaning and sterilization while ensuring Annex 1 compliance and full customization.