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  1. Inside The Development Of An AAV8 Production Platform 4/24/2025

    Explore innovative solutions for AAV8 production challenges, which include scalability and purity, as well as learn how a collaboration with CDMO Matica Biotechnology ensures efficient, high-yield gene therapy vector production.

  2. Characterizing Binding Interactions By ITC 4/24/2025

    Isothermal Titration Calorimetry is a powerful technique for analyzing biochemical binding events, which is crucial for understanding molecular interactions and enzyme kinetics in biomedical research.

  3. FDA RIFs Might Delay Your Review — Here Are Tips For Mitigating 4/24/2025

    Mounting concerns that FDA reviewers could start missing PDUFA deadlines have put many on edge. The moment calls for defensive and offensive strategies.

  4. PDG-FDA Town Hall Notes — DSCSA Readiness Is At Hand 4/24/2025

    Data quality and exceptions handling were key discussion points during a March PDG-FDA town hall, where stakeholders shared updates on progress and unfinished work.

  5. ICH Revises Q1 Guideline, Advancing Stability Testing Standards 4/24/2025

    In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.

  6. Comprehensive CMC-QC Solutions For Cell Therapy 4/23/2025

    Learn about comprehensive solutions for cell therapy quality control, including CAR/TCR detection, residual testing, and potency assays, ensure stability, multi-batch validation, and adherence to strict quality standards.

  7. CytoPak Products: Closed Process Solutions For Cell Therapy 4/23/2025

    Enhance cell therapy workflows with cutting-edge closed-system solutions that simplify processes and support consistent cell growth from research to commercial production.

  8. CAR Expression Detection Using Fluorescent Labeled Proteins, Flow Cytometry 4/23/2025

    Learn how site-specific fluorescent labeling addresses key challenges in flow cytometry-based evaluations by enhancing assay sensitivity, reducing variability, and ensuring reliable results.

  9. Rapid Discovery And Characterization Of Monoclonal Antibodies Against The SARS-CoV-2 Delta Spike Protein 4/23/2025

    Delve into the intricate workflow employed for the discovery and characterization of monoclonal antibodies (mAbs) targeting the Delta spike protein.

  10. Leveraging Efficiency From CLD To Clinical Manufacturing Of mAbs 4/23/2025

    Discover how our efficient strategies can propel your mAb from discovery to clinical manufacturing in as little as 18 months.