Expert Insights On Cell Line Development

  1. How Ring's Single-Capsid Protein Approach Optimizes Viral Delivery 11/5/2024

    Complexity and manufacturability have an inverse relationship. Ring’s platform seeks to simplify highly complex gene therapy production by making the most of biology.

  2. What's In The Leukopak Matters For Cell Therapy Manufacturing 10/11/2024

    Advanced cell-based therapies are impossible without high-quality leukopaks from high-quality donors.

  3. 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.

  4. 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.

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 FDA's Draft Guidance On Safety Testing Of Human Allogeneic Cells For Use In Cell-Based Therapies 5/24/2024

    This article provides a summary and analysis of the FDA's new draft guidance, Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products.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

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 Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of Cell & Gene Therapy Products 5/23/2024

    FDA has released the new draft guidance for industry, Considerations for the Use of Human- and Animal-Derived Materials in the Manufacture of Cellular and Gene Therapy and Tissue-Engineered Medical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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.