Expert Insights On Downstream Bioprocessing

  1. Bacterial Endotoxin Testing, Part 3: Calculating Endotoxin Limits & MVD 7/30/2024

    The author continues his article series on bacterial endotoxin testing by discussing depyrogenation and calculating endotoxin limits and maximum valid dilution (MVD), including those for active substances and excipients, combination products, and medical devices.

  2. Bacterial Endotoxin Testing, Part 2: Prerequisites & Reagent Preparation 7/23/2024

    In this second article of a planned series about bacterial endotoxin testing, the author shares best practices about prerequisites and reagent preparation for a gel clot Limulus amebocyte lysate (LAL) test.

  3. How Eli Lilly's Making Peptides Faster And More Reliably 7/17/2024

    Three company leaders answer questions about the IE2b project, which is receiving an ISPE 2024 Facility of the Year Award for its ingenuity of complexity.

  4. Bacterial Endotoxin Testing, Part 1: Overview 7/16/2024

    All injectable drug products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins. This article provides an overview of bacterial endotoxin testing and the LAL method.

  5. More Case Studies: Managing Change In Vaccine Production 7/15/2024

    Part two of this series digs into real-world examples from Sanofi for getting the right stakeholders on board when altering a process or changing equipment.

  6. End-To-End mRNA DS And DP Manufacturing Processes 7/10/2024

    This article demystifies the manufacture of mRNA encapsulated in lipid nanoparticles across unit operations for plasmid linearization, drug substance (DS) manufacture, and drug product (DP) manufacture.

  7. Does Single-use Seem Daunting? Try Starting With Standard Assemblies 7/8/2024

    You might not need to outfit your whole facility to take advantage of single-use technology. Assemblies offer a straightforward path to standardizing equipment.

  8. Using The ADKAR Model In Biopharma Change Management 7/8/2024

    Biopharma companies dedicated to continuous improvement are the ones that dominate their market sector. Using the ADKAR model of change management can help.

  9. Making Cancer Vaccines Is Complex; New Platform Guidance Could Help 7/3/2024

    FDA's draft guidance on platforms is mostly for established, well-characterized modalities, but it also has implications for the emerging area of personalized medicine.

  10. Strategies To Tackle CAR-T Product Challenges 6/24/2024

    This article describes strategies for scaling up production of CAR-T products, including the hub model, bedside model, innovation of process strategy, and more.