Industry Insights

  1. Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots 10/31/2025

    The terms “confirmatory" and "conformance" batches are inconsistently used in the industry. Since process validation is essential for maintaining compliance and detecting variability, we must work toward harmonization of the terms to avoid confusion.

  2. Are You Still Evaluating CMOs When You Really Need A CDMO? 10/29/2025

    Outsourcing adds capacity and specialized knowledge to your supply chain. But contractors come in several types. Here's how to pick the right one.

  3. How Early Manufacturing Decisions Shape Long-Term Success 10/27/2025

    Early manufacturing choices in cell and gene therapy shape long-term clinical and commercial success, so leaders from Allogene and Verismo emphasized that both autologous and allogeneic developers should prioritize process simplicity, risk-based decision-making, and adaptable manufacturing as therapies move from concept to clinic.

  4. Here's A Thought: What If Gene Editing Didn't Use Bacterial Enzymes? 10/27/2025

    Citing the dismally few wins for CRISPR/Cas9 and other gene editing systems, one scientist proposes delivering zinc finger DNA-binding peptides using AAV6 vectors.

  5. Analyzing CAR-T Surface Proteins With Immunoprecipitation Coupled With Mass Spectrometry 10/24/2025

    Among other benefits, the approach can help compare CAR constructs, evaluate the effects of manufacturing processes, and monitor changes in protein interactions.

  6. Regulatory Pathways — With Real-Life Examples — For Successful CGT Clinical Trials 10/24/2025

    Discover the most effective regulatory pathways used to support CGT development, including two real-life examples.

  7. Program Manager Alignment And Integration: Best Practices When Working With A CDMO 10/23/2025

    This Q&A discusses best practices for integrating program managers into a sponsor company and how program managers help bridge the gaps between various stakeholders.

  8. New Guide Aims To Build Robust Framework For Digital Validation Tools 10/22/2025

    The ISPE's new guide addresses software for managing digital assets related to qualification, verification, validation, and compliance assurance.

  9. Pfizer's Accord For A Healthier World Program Challenges Stability Study Norms 10/22/2025

    The company developed a novel approach to address the historic lack of stability testing for underserved parts of the world, near the equator.

  10. The 9 Fastest-Growing Outsourcing Segments 10/21/2025

    Capacity isn’t the choke point—capability is; this piece ranks nine fast-growing outsourcing segments and shows sponsors how to win by locking in modality-proven partners early.