Expert Insights On Upstream Bioprocessing

  1. How To Minimize The Impact Of Stability Testing On Gene Therapy Batch Yield 8/27/2024

    This article outlines strategies for reducing the volumes required for gene therapy stability studies, with the goal of conserving product for patients, while remaining compliant and delivering data on CQAs. 

  2. NIST, IBBR Researchers Explore Excipient-Influenced mAb Dynamics At Atomic Level 8/16/2024

    Nuclear magnetic resonance spectroscopy is powerful technique used to investigate the structure and dynamics of the drug substance in various drug formulations.

  3. Report: Single-use Bioreactor Uptake Plateaued, Other SUT On The Rise 8/12/2024

    BioPlan Associates' latest manufacturing survey found signs of a maturing market and strong demand for innovation upstream and downstream.

  4. Harnessing Analytics To Minimize Antibody Variants And Speed Up Development 7/30/2024

    Antibody heterogeneity comes in many flavors — size and charge variants, and from post-translational changes. To control them, start with thorough characterization.

  5. Uncovering Cell Culture Media's Part In Latest Biopharma Trends 7/19/2024

    Cell culture media are ubiquitous in just about every bioprocess system, and advanced modalities are putting specialty media in the spotlight.

  6. 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.

  7. 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.

  8. 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.

  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    FDA's draft guidance on platforms is mostly for established, well-characterized modalities, but it also has implications for the emerging area of personalized medicine.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. Does Flow Play A Role in Protein Aggregation During Bioprocessing? 6/7/2024

    We know about many factors that trigger protein aggregation, but does fluid flow itself play a part? These scientists at the University of Leeds are working to find out.