Business of Biotech Shorts

  1. 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.

  2. 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.

  3. 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.

  4. How To Avoid A Biosimilar Comparative Efficacy Study, If Possible 4/20/2026

    Few companies, if any, would ever eagerly volunteer to perform a comparative efficacy study (CES) for their biosimilar candidate. The FDA has been clear all along that compelling a CES remains a tool in its toolbox if the agency believes it's necessary. So what might trigger one, and how can companies avoid it?

  5. 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.

  6. Building A Comprehensive Control Strategy For Biosimilar Analytics 4/20/2026

    Like many other biologic drugs, building a comprehensive controls strategy for biosimilars starts with defining critical quality attributes (CQAs), said Vince Narbut, a principal consultant at Biologics Consulting Group, during Bioprocess Online Live: Process Control's Increasing Role In Biosimilar Approval.

  7. Standards' Role In Biosimilarity Assessment 4/20/2026

    Standards are useful tools for specific purposes, but they represent a one-point target. They do not capture the full range of variability found in reference products on the market.

  8. Protecting Biopharma Manufacturing Supply Chains 2/5/2026

    In this final segment from the Bioprocess Online Live event, “Protecting Bioprocessing Operations and Supply Chains In A Turbulent Economy,” panelists Adam Golin, Jon Lindbloom, and James Sapirstein share their advice and best practices for sourcing suppliers and staying agile during periods of change in the industry.

  9. Building Resilience In Biomanufacturing Operations 2/5/2026

    In this segment from the Bioprocess Online Live event, “Protecting Bioprocessing Operations and Supply Chains In A Turbulent Economy,” panelists share their thoughts on what it means to be resilient and how organizations can embody resilience in their biomanufacturing, which in part requires agility and preparation for the worst-case scenario. The panel was in agreement that earlier-phase companies have the highest opportunity to bake resilience into their operations.

  10. How Will U.S. Tariffs And The BIOSECURE Act Impact Global Biopharma Markets? 2/5/2026

    In this segment from the Bioprocess Online Live event, “Protecting Bioprocessing Operations and Supply Chains In A Turbulent Economy,” panelists explain how tariffs imposed by the U.S. are putting competitive pressure on companies to reduce COGs. They also discuss the short- to long-term impact of efforts to onshore biomanufacturing.