CLINICAL SUPPLY MANUFACTURING RESOURCES

• Prepping For Commercialization Through Supply Chain Logistics

  While cell and gene therapies are bringing new hope to patients experiencing rare and serious diseases, uncover how they're disrupting the biopharma market in new and challenging ways.

• A Supply Chain Management Solution Designed for Clinical Research

  In this use case, follow along the clinical supplies management journey to learn how GxP Inventory replaces fragmented, spreadsheet-based processes to optimize visibility, traceability, and compliance.

• Functional Testing Summary Of Daikyo Crystal Zenith Nested Vials

  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.

• Clinical Manufacturing: What It Is And How It Works

  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?

• Sponsor Overcomes Hold And Steers Products Through Development

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

• Specializing In Small And Early-Stage Partners, Not Just Small Batches

  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.

• Outsourcers Are Feeling Uneasy About Continuity Of Supply

  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.