Clinical Supply Manufacturing Recources

  1. Faster From Formulation To Fill/Finish 7/12/2022

    Optimize your speed to clinic by securing a development and aseptic fill/finish partner to support your applications with the right manufacturing equipment, communications, and SOPs.

  2. Lifecycle Planning For Containment And Delivery Of Biologics Drug Products 6/20/2024

    Read more about trends in the biologics market that could impact the lifecycle strategies for your drug product and steps you can take around drug packaging early in development.

  3. What Are Decentralized Clinical Trials (DCTs)? 8/23/2022

    Discover how DCTs leverage “virtual” tools, such as telemedicine, sensory-based technologies, wearable medical devices, and direct delivery of study drugs and materials to patients’ homes.

  4. Inside A Gene Therapy Facility, Commercialization & Industrialization Project 3/10/2021

    An inside look at a clinical-stage company focused on bringing its gene therapy from the lab into a clinical setting for patients and families devastated by rare neurological genetic diseases. 

  5. 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.

  6. Developing A Strategy To Optimize Study Supplies 9/1/2022

    Discover how the optimization of a clinical supply strategy can decrease wasted supplies, drive down costs, and ensure supplies reach the sites on time and in the correct quantities.

  7. 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.

  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. 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.

  10. Building A Global Cell And Gene Supply Chain Serving Personalized Medicine 3/28/2022

    Clinical distribution paths can be fragile for a multitude of reasons, making it critical that pharmaceutical sponsors and their partners orchestrate supply chain logistics even before site initiation.