Expert Insights On Upstream Bioprocessing

  1. 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.

  2. 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.

  3. 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.

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    FDA's draft guidance on platforms is mostly for established, well-characterized modalities, but it also has implications for the emerging area of personalized medicine.

  5. 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.

  6. Balanced Sourcing Of Custom Media/Buffer Formulations, Part 2: The Case For Insourcing 6/6/2024

    In part 1 of this 2-part series, the authors discussed the case for outsourcing of custom media/buffer formulations. In this article, they discuss key considerations in the case for vertical integration, or insourcing.

  7. FDA's Draft Guidance On Safety Testing Of Human Allogeneic Cells For Use In Cell-Based Therapies 5/24/2024

    This article provides a summary and analysis of the FDA's new draft guidance, Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products. The public comment period ends July 29.

  8. How Advanced PAT Aids Quality By Digital Design In mRNA Manufacturing 5/15/2024

    QbDD is an improvement over the QbD paradigm. Here, computational models are used to characterize, monitor, control, and improve manufacturing processes.

  9. Evaluating, Validating, And Implementing NAT-Based Mycoplasma Detection Methods 5/3/2024

    Regulatory authorities advocate using alternative adventitious agent tests, but adoption has been slow. Here’s how to validate an alternative mycoplasma detection assay.

  10. Forum Notebook: Quick Takes From USP's mRNA Virtual Summit 5/1/2024

    The United States Pharmacopeia held a forum in February to exchange ideas about analytical methodologies and release testing. Here's a recap of the event.