Clinical Supply Manufacturing Recources

  1. Cold Chain Services For Clinical Trial Success

    As innovative, complex therapeutics advance toward clinical trials, properly handling, storing, and packaging temperature-sensitive critical materials is essential to maintain product integrity.

  2. Outsourcers Are Feeling Uneasy About Continuity Of Supply 4/14/2022

    Find out how COVID-19 complications have picked up from the first year, with more outsourcers experiencing bigger obstacles when it comes to manufacturing, specifically with drug product.

  3. Specializing In Small And Early-Stage Partners, Not Just Small Batches 8/16/2023

    Many small and/or early-stage companies are not aware of the need, or the possibility, of finding a CDMO that specializes in meeting their specific requirements.

  4. The Use Of Injectable Packaging From Early Development To Commercialization 2/20/2024

    While in their early-stage development of a mAb biosimilar for oncology treatment, a large biopharmaceuticals company sought a packaging recommendation: a stopper to maintain high-quality standards.

  5. Packaging And Containment: Get Your Products To Market Faster

    Learn more about why focusing on packaging solutions early on can keep development on track, help you meet milestones, and get your product to market faster.

  6. Developmental Testing Of IV Solutions 2/10/2022

    As IV-administered drugs proliferate, sponsors must understand the associated regulatory requirements, methodologies for useful/required information, and formulations suitable for administration.

  7. Reaching First-In-Human Trials Faster: Connect With The Right Partner

    Assessing outsourcing partners’ credentials in people, technology, supply chains, and integration will make all the difference as sponsors aim to streamline processes on the path to commercialization.

  8. Ensure Seamless, Efficient Delivery Of Clinical Trial Materials Worldwide 1/12/2023

    Drug discovery companies, CROs, and CDMOs are under pressure to find supply management solutions that ensure delivery of clinical trial materials while navigating complex study designs and the regulatory landscape.

  9. Understanding Injectable Drug Container Closure Systems 6/20/2024

    Choosing the right container closure system (CCS) format is crucial, so understanding the different parts involved, their functions, storage requirements, and how they impact administering the drug is essential.

  10. Vial Containment Systems For Gene And Cell Therapies 5/24/2024

    CZ vial-stopper-seal combinations offer a viable solution for the challenges associated with low-temperature storage of cell therapy drug products.