Industry Insights

  1. The BPCIA And Declaratory Judgment: The Real Dance Partners? 2/17/2021

    In theory, the initial exchange process in the first phase of litigation is intended to whittle down the number of patents and initiate resolution of any disputes during FDA review of the aBLA. However, despite its high-minded objectives, litigation under the BPCIA has proven less harmonious than planned. 

  2. Your Next Tech Transfer Should Include These Modern Tools 5/5/2023

    Technology transfer is a Herculean sharing exercise with reams of data traveling back and forth between sponsor and manufacturer. Contemporary tools and strategies make the task easier. This article digs into some of them.

  3. Selecting Drug Delivery Systems For Higher Doses, Viscosities And Lower Risk 1/18/2022

    Discover how companies can de-risk their device selection as they bring this new generation of high-volume, high-viscosity biologics to market.

  4. Process Mapping For More Effective Knowledge Management 2/26/2024

    It takes a patchwork of knowledge from multiple complementary mapping tools to generate the process knowledge needed for success in pharmaceutical and biologics manufacturing.

  5. 2024 LIMS Trends 3/15/2024

    The laboratory information management system (LIMS) landscape in 2024 is a dynamic one, driven by accelerating advancements in technology and evolving industry needs. This article shares the four key trends.

  6. Biopharmaceutical Packaging Solution Advancements And Considerations

    Explore how to develop a strong packaging system, and learn more about why a reliable supply chain is critical for drug substance and drug product transport.

  7. When The hMSC Meets The AAV 1/3/2023

    Learn more about plausible benefits of AAV’s use in concert with hMSCs, and how a complete genetic engineering medium was expanded beyond lentivirus.

  8. Planning & Executing Small-Scale Model Qualification For Upstream & Downstream Biopharma Processing 5/19/2021

    As the second article in a three-part series that summarizes the discussions and exchanges of a BioPhorum Development Group workstream on small-scale model (SSM) justification, this article covers the current opinion on how to execute small-scale model qualification for both upstream and downstream SSMs and analytical setup. 

  9. How 'Explainable ML' Can Improve Process Performance 1/23/2025

    In a case study, chromatography process data converted into "images" equipped artificial intelligence to help manage dynamic binding capacity degradation.

  10. Why Manual CQV Costs More Than You Think 5/6/2025

    Discover how modernizing commissioning, qualification, and validation processes in pharmaceutical and biotech manufacturing can streamline operations, reduce risks, and enhance efficiency to ensure compliance.