Regulatory Articles. App Notes, Case Studies. & White Papers

  1. Filling Gaps In Drug Discovery Pipelines: From Candidate To Clinic 6/5/2026

    See how existing partnerships with NIH allowed the chance to bring together government, academic, and industry resources through strategic initiatives that streamline processes and maximize benefits.

  2. Mammalian Expression 5/28/2026

    See how a biotechnology company advanced an engineered protein therapeutic while navigating development, regulatory, and scalability challenges. 

  3. Workflow For Chemical Characterization And Database Curation 5/28/2026

    Confident identification of known and unknown compounds starts with smarter LC/MS and GC/MS workflows. Learn how structure elucidation, verification, and centralized data curation work together.

  4. How Data Management Is Enhancing Pharmaceutical Development 5/19/2026

    Disconnected data slows process chemistry. See how integrated access to process and analytical data can cut data handling time, improve collaboration, and support stronger decisions across development.

  5. FDA's New Flexible CMC Framework For CGT 4/14/2026

    The FDA is rethinking CMC oversight for cell and gene therapies, prioritizing science‑based justification over rigid validation models. Learn how this lifecycle‑focused approach could reduce burden.

  6. Industry Innovators: APAC's Sharp Advanced Therapeutics Edge 3/17/2026

    APAC is rapidly advancing its role in the global therapeutics landscape, fueled by faster development models. Learn how this momentum is reshaping expectations for innovation and commercialization.

  7. Development Of A Non-Standard Protein Therapeutic 2/4/2026

    Discover how a tailored development approach transformed a complex therapeutic protein into a candidate ready for early-stage clinical trials.

  8. Flow Chemistry For Contemporary Isotope Labeling 1/26/2026

    Gain insight into how late‑stage exchange and flow‑based methods enable efficient access to labeled molecules for pharmaceuticals, mechanistic studies, and analytical applications.

  9. Your Biosimilar, Your Journey 10/20/2025

    With many blockbuster drug patents set to expire by 2030, the market is ripe for biosimilar developers to stake their claim. To succeed, they must be strategic and compliant.

  10. A Risk-Based Approach To Plasmid DNA And mRNA Process Development 9/23/2025

    Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.