Insights On CONTRACT PHARMA MANUFACTURING

  1. The Future Of CGT: Phase-Appropriate Plasmid DNA Manufacturing 10/16/2025

    Effective CGT development hinges on phase-appropriate manufacturing. Matching manufacturing rigor to the clinical phase ensures the right quality at the right time while reducing costs and accelerating timelines.

  2. Streamline Biopharmaceutical Manufacturing With Versatile Platforms 10/16/2025

    Gain insights into how standardized quality controls, robust analytics, and streamlined processes can improve efficiency, reliability, and scalability across the development lifecycle.

  3. Integrated Manufacturing To Mitigate CMC Risks, Simplify Commercial Supply 10/15/2025

    Leveraging cross-functional coordination between sites, harmonized tech transfers, one quality system, and synchronized team activities can streamline regulatory submissions and deliver high-quality commercial outcomes.

  4. From First-In-Human To Proof-Of-Concept — Quicker, Smarter, Streamlined 10/14/2025

    Explore examples of smarter SAD/MAD trial designs including multi-part and hybrid protocols, regulatory foresight, recruitment considerations, and operational strategies that keep programs moving.

  5. Building A Path To Approval With Effective Regulatory Support 10/14/2025

    When partnering with CDMOs, success depends heavily on collaboration with a partner that combines deep technical expertise with a proven record of regulatory excellence and operational reliability.

  6. Know Your Product, Know Your Path: A Primer On Advanced Therapy Development 10/9/2025

    To prevent path-to-market setbacks, it is critical to develop a Chemistry, Manufacturing, and Controls strategy that proactively identifies scientific and compliance gaps, as well as mitigates risk.

  7. Your Guide To Minimizing Scope Creep For Pharma Projects 10/8/2025

    By adopting these best practices, biotech sponsors can foster more transparent, efficient, and productive collaborations with their CDMO partners.

  8. The Commercial Advantage Of Softgels 10/8/2025

    Among oral dosage forms, softgel capsules stand out as a versatile and high-performance option — offering superior delivery characteristics, consumer appeal, and brand differentiation.

  9. Managing Cell Therapy Investigational New Drug (IND) Timeline Risks 10/7/2025

    Managing timelines to IND is the top challenge in cell therapy, impacting funding, patent value, and patient access amid competitive, capital-constrained development environments.

  10. Key CMC Step For Cell Therapy IND Success 10/7/2025

    Ensure cell therapy products are consistently manufactured with safety, quality, and potency, supporting regulatory approval and successful clinical development.