Insights On Drug Development

  1. Part One: Challenges In LVV Purification And Quantitation 6/6/2025

    Discover how a company is overcoming purification challenges and advancing scalable, GMP-ready LVV manufacturing for gene and cell therapies.

  2. Navigating OOX Results: Effective Analysis, Management In CDMO Labs 6/5/2025

    By prioritizing the management of Out of Expectation (OOX) results within your CDMO laboratory, learn how you can ensure product integrity, patient safety, and unwavering regulatory compliance.

  3. Analytical Techniques For Assessing Quality Of Therapeutic Proteins 6/5/2025

    Evaluating quality attributes of therapeutic proteins requires a strategic, regulation-compliant selection of analytical techniques that consider molecular characteristics and phase to ensure characterization.

  4. Simplify CAR-T Cell Manufacturing With LNP-Mediated Delivery 6/3/2025

    Streamline CAR-T cell manufacturing with lipid nanoparticles delivering base editors to create fratricide-resistant, CD45-edited CAR45 T cells, which enables scalable, precise, and potent therapies for blood cancers.

  5. Versatile Lipid Nanoparticle Platform For Efficient Gene Editing 6/3/2025

    Lipid nanoparticles enable efficient gene editing in hard-to-transfect cells like T-cells and blood stem cells, which offers scalable, clinically relevant methods for developing advanced therapies for cancer and rare diseases.

  6. A New Look At Subcutaneous mAb Delivery Using Nanoformed Particles 6/3/2025

    A highly concentrated non-aqueous suspension of an IgG1 was developed using a patented platform. Review how the particle size of the monoclonal antibody (mAb) impacts the overall behavior of the drug product.

  7. Leveraging Robust Immunogenicity Assessments To Mitigate Clinical Risks 6/2/2025

    By improving the granularity and interpretability of preclinical immunogenicity data, EpiScreen® 2.0 supports more confident lead selection and helps mitigate downstream clinical risks.

  8. Key Bioassay Strategies For Successful IND Submission 6/2/2025

    Watch Erika Kovacs, Senior Director of Bioassay, as she discusses critical considerations for developing stage-appropriate bioassays to support complex biologics and bioconjugates on the path to IND.

  9. Advancements In Evaluating Fc-Mediated Functional Activity In Biologics 6/2/2025

    Watch this presentation to gain a comprehensive overview of how to evaluate Fc-mediated functions — and why doing so is vital to the success of biologic therapies.

  10. Timing Is Everything: Choosing The Right Bioassay To Increase Success 6/2/2025

    Discover how phase-appropriate bioassays deliver regulatory-compliant, decision-ready data — from early discovery to commercial production.