Clinical Supply Manufacturing Recources

1. 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.

2. 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.

3. Designing An Optimal APAC Clinical Supply Chain

   Gain the knowledge and skills needed to effectively navigate the complex clinical supply distribution landscape within this important and rapidly growing region.

4. Speed To Market – API Large-Scale Commercial Manufacturing 1/20/2022

   Learn how a top 20 US-based pharma company achieved more capacity to meet commercial supply needs in an accelerated timeline followed by pre-approval inspection with the help of a CMO partner.

5. Winning The Race To FPI With Early Randomization And Trial Supply Management 9/8/2022

   Learn why the ability to get investigational products to sites, and appropriately store them, is not a given – and this oversight can have serious consequences. 

6. Clinical Manufacturing: What It Is And How It Works 2/27/2022

   Clinical manufacturing is a specialized form of pharmaceutical manufacturing focused on producing drugs for clinical research. How does it work and how is it different from commercial manufacturing?

7. 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.

8. 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.

9. 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.

10. Controlled Substances In Clinical Trials 3/30/2023

    Handling controlled substances presents layers of complexity. Partnering with an experienced CDMO is essential for managing scheduled materials during clinical studies.