Industry Insights

  1. Translating Study Reports – A GLP Draft Guidance 5/6/2024

    The FDA has provided guidelines for the translation of studies conducted by non-US testing facilities, including an expectation that the translated report include a statement of certification requirements.

  2. Optimizing CAR T-Cell Development Starts With Your Cell Incubator 7/22/2025

    Explore how precise cell culture conditions are critical to advancing CAR T-cell therapies, which empowers researchers to develop more effective cancer treatments and accelerate breakthroughs.

  3. 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.

  4. Improve The Design And Delivery Of Your AOC With ThioBridge™ 4/14/2025

    Learn how advanced site-specific conjugation technologies are redefining the next generation of ADCs with enhanced stability, homogeneous DAR, and streamlined development.

  5. Bacteria Media Optimization Using In Silico Strategies 2/21/2024

    Determining ideal media composition for a bacteria is critical because it fosters a satisfactory grow rate, allowing the bacteria to reach the required growth yield.

  6. Essential Drug Delivery Outputs For Devices To Deliver Drugs, Biologics 5/16/2025

    All future submissions are expected to align with FDA's draft guidance that clarifies the agency's expectations for establishing, evaluating, and controlling Essential Drug Delivery Output (EDDO) requirements.

  7. Let's Stop Treating Allogeneic Cell Therapy As One Thing 7/14/2026

    Industry is beginning to accept that allogeneic cell therapy spans categories, and success depends on aligning biology, regulation, and economics unique to each product.

  8. Using AI In Drug Discovery Isn't The Golden Solution You Think It Is — Yet. 7/17/2023

    Before we realize the true potential of advanced artificial intelligence (AI) and machine learning (ML) technologies to treat disease, we need to start by developing technologies that can generate the massive amounts of reliable, high-quality biological data that make up the fundamentals of any AI/ML approach.

  9. Unlocking The Future: Exploring Cutting-Edge Cell And Gene Therapies 8/12/2024

    Explore the transformative potential of cutting-edge cell and gene therapies, focusing on CAR-T cell therapy, CRISPR-Cas9 gene editing, and other advanced approaches.

  10. How To Use Precipitation, Not Protein A Chromatography, For mAb Capture 1/4/2024

    Protein A chromatography is a key bottleneck in mAb manufacturing. Precipitation, an early separation technique, has emerged as a ready solution for continuous manufacturing.