Regulatory

31. In The U.S., Pharmacy-Level Biosimilar Substitution Remains A High Bar 4/20/2026

    Recent changes in the FDA's biosimilarity assessment guidance do not address the other side of the biosimilar coin, interchangeability. Unique to the U.S., pharmacy-level substitution is allowed only when companies clear an additional regulatory hurdle of receiving an interchangeability designation.

32. Multi-Specific Antibody Development: What Challenges The Need For Speed? 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 why the industry is pursuing faster, more cost-effective multi-specific antibody development and some of the major challenges standing in the way of efficiency.

33. The Necessity Of Potency Assay Matrices For Complex Proteins 4/20/2026

    For complex proteins, the FDA requires a matrix of orthogonal potency assays. Sponsors must assess all functional activities of a product, especially when the mechanism of action is known.

34. Cell And Gene Therapy Innovations 5/19/2025

    This interview with a pharmaceutical analytics expert discusses key insights into advances in cell and gene therapy and the strategies used to support customers in improving their therapeutic development.

35. 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.

36. 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.

37. 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.

38. 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.

39. 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.

40. An Efficient And Reliable Way To Digitalize Your Sterility And QC Testing Data 5/2/2023

    Watch to learn about the M-Trace™ Electronic Test Record Software, your digital QC companion for trusted and efficient data recording that automizes and digitalizes your sterility and QC testing data.