Regulatory

  1. Criticism Of FDA's Limited Proof-Of-Principle Ignores The Full Breadth Of Biosimilar CQA Understanding 4/20/2026

    Critics say adalimumab and trastuzumab, two of the most well-characterized antibodies on the market and each with their several approved biosimilars, provide a limited basis for proof of principle. During Bioprocess Online Live: Process Control's Increasing Role In Biosimilar Approval, panelists agreed that the full body of evidence includes approved biosimilars with diverse mechanisms of action and complex glycostructures.

  2. Fill And Finish: Your Final Step Is Our First Priority 12/9/2025

    Fill and finish demands precision, compliance, and adaptability. Learn how flexible solutions and expert support can help you overcome complexity, reduce risk, and ensure quality in this final step.

  3. Regulatory And Biosafety Testing Expertise 3/31/2026

    Advancing biologics requires confidence in safety, quality, and compliance. Learn how integrated analytical and biosafety testing, backed by decades of expertise, helps reduce risk.

  4. Platforming And The Future Of Standardized Manufacturing Chassis 4/20/2026

    Platforming downstream processes offers efficiency gains, while upstream processes are standardizing on high-intensity perfusion or fed-batch. Robust analytical data allows for modern efficiencies like single-use systems.

  5. Legal & Compliance Impact On Speed In The Antibody Market 8/9/2023

    In this segment of the Bioprocess Online Live event, Process Development For A Diverse mAb Pipeline, Bayer’s Sr. Director, Bioprocess Technologies, Amir Goudarzi, Ph.D., addresses questions on regulatory impacts on multi-specific antibodies’ path to market, and how biopharma legal and compliance professionals can expedite the journey.

  6. Developing Antibodies To Block Neuroinflammation With MindImmune's Stevin Zorn, Ph.D. 10/20/2025

    In this episode of "Better Biopharma," host Tyler Menichiello is joined by MindImmune's president and CEO, Stevin Zorn, Ph.D. They discuss the development of the company's lead candidate, MITI-101, a monoclonal antibody designed to prevent peripheral immune cells from entering the brain and driving neuroinflammation linked to Alzheimer's disease.

  7. Strategies To Reduce Regulatory Risks In Gene Therapy 5/15/2020

    Learn how to mitigate regulatory risk for your gene therapy process.

  8. 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.

  9. 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.

  10. A Straightforward Path Toward Regulatory Compliance & Data Integrity With Your Microbial Testing Systems 11/10/2025

    In this webinar, we will share a variety of strategies for implementing and validating microbial identification systems in the cGMP environment, possible difficulties along the way, and a comprehensive solution that addresses these challenges.