Expert Insights On Cell Line Development

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 FDA's Draft Guidance On Safety Testing Of Human Allogeneic Cells For Use In Cell-Based Therapies 5/24/2024

    This article provides a summary and analysis of the FDA's new draft guidance, Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products.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

  2. Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of Cell & Gene Therapy Products 5/23/2024

    FDA has released the new draft guidance for industry, Considerations for the Use of Human- and Animal-Derived Materials in the Manufacture of Cellular and Gene Therapy and Tissue-Engineered Medical Products. This article provides a summary — and shares what is shocking about the guidance.

  3. 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.

  4. Cell Counting Is Growing More Important Amid Advanced Therapy's Rise 4/12/2024

    You can't improve what you don't measure. This discussion explores advances in cell counting technology and the growing number of ways it aids the biotech industry and beyond.

  5. Stable Cell Lines: Stepping Stones For Continuous Viral Vector Manufacturing 2/14/2024

    Amid the increasing need for greater volumes of therapeutic molecules, proteins, and viral vectors, a promising technology started to develop — the stable cell line.

  6. It's Time To Dethrone CHO When It Comes To mAb Production 2/1/2024

    Let’s be honest — CHO is an expensive, inefficient, and pervasive way to make mAbs. Emerging and evolving alternatives discussed here include microbial systems, which tend toward better efficiency.

  7. Novel Approaches For Obtaining High-productivity Clones 1/30/2024

    Let's dig into cell line selection approaches, transposons to increase copy number for the gene of interest, and targeted integration to rapidly obtain high-productivity clones.

  8. Developing A Viral Gene Therapy Manufacturing Process 1/23/2024

    There is a growing popularity of adeno-associated virus (AAV) for delivering in-vivo gene therapies, a growing preference of transient transfection systems by biologics companies, and an increasing number of CDMOs offering this system as a platform process. This article describes a transient transfection AAV manufacturing process that uses a triple plasmid transfection strategy into HEK293T cells.

  9. Why Lactococcus Lactis Might Be The Best Membrane Protein Factory 11/17/2023

    The bacteria lactococcus lactis has emerged as a promising alternative expression system for membrane proteins, which are difficult to manufacture. L. Lactis is inexpensive and easy to grow. It also doesn't produce endotoxins, which makes it a good fit for therapeutic applications.

  10. Balanced Sourcing Of Custom Media/Buffer Formulations: The Case For Outsourcing 8/10/2023

    Nothing is risk-free; now more than ever, all sourcing options have pros and cons that we need to assess to find the best fit. In this first article of a two-part series, we share three compelling reasons to consider outsourcing, along with key considerations for each.