Clinical Supply Manufacturing Recources

  1. A Smart Solution To Clinical Supply Management 10/28/2022

    Delve into a solution that ensures the efficient delivery of trial materials worldwide, while navigating the challenges of more complex study designs and the ever-evolving regulatory landscape.

  2. Overcoming Cell Therapy Supply Chain Challenges 5/11/2021

    For the industry to realize the potential of cell and gene therapies (CGTs), we must develop improved solutions that reliably support the control and transport of critical CGT raw materials and products.

  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. Addressing Rare Disease Drug Product Manufacturing Challenges 2/22/2023

    Handling development and manufacturing challenges for orphan drugs requires experience, expertise and scalable technologies, along with a flexible and agile supply chain.

  5. Functional Testing Summary Of Daikyo Crystal Zenith Nested Vials 5/24/2024

    The Daikyo Crystal Zenith nested vials meet the exterior dimensions of the glass standard ISO 8362-1. The vials maintain CCI for up to 6 months and can withstand ultra-cold temperatures and drop conditions.

  6. 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.

  7. GxP Inventory Solution Improves Clinical IP Efficiency And Compliance 8/8/2023

    Learn how this biopharmaceutical research sponsor was able to centralize and digitalize the processes involved in clinical supply production through distribution using GxP Inventory.

  8. Sponsor Overcomes Hold And Steers Products Through Development 11/2/2023

    Uncover how a small-sized biotech company was able to resolve critical regulatory CMC deficiencies to meet FDA requirements.

  9. 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.

  10. Developing Injectable Drug Placebo Formulations For Clinical Trials 1/9/2024

    Developing a placebo for an injectable drug requires consideration of the formulation’s impact in trials, chemistry and physical details, ethical concerns, and regulatory compliance.