Clinical Supply Manufacturing Recources

1. 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.

2. A Supply Chain Management Solution Designed for Clinical Research 8/4/2023

   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.

3. 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.

4. De-Risking Your Bioconjugate's Path To Clinical Manufacturing 9/30/2022

   Explore the challenges when moving a bioconjugate candidate from early development to clinic, along with integrated solutions for navigating this growing area of the biopharmaceutical industry.

5. Desired Integrated Clinical Logistics Activities 8/15/2022

   Learn why clinical labeling, clinical supply chain management, and storage and distribution of clinical trial materials received the most votes in a survey of 100 sponsors outsourcing clinical logistics.

6. 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.

7. Solving Logistic Complexities In The Era Of Personalized Medicine 1/1/2022

   Examine how the next generation of therapies is disrupting supply chain logistics and explore solutions for the complexities within cell and gene therapies.

8. 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.

9. Safeguarding Cell Therapy Cryopreservation: Primary Containers 5/20/2024

   Review different aspects of container selection from the perspective of cryopreservation that are may be overlooked but critical for the quality of cell therapy drug products.

10. Key Considerations For Selecting Fill/Finish Manufacturing Technologies

    Obtaining information and proactively mapping out your fill/finish strategy early can de-risk an investment in equipment or processes, ensuring you meet your long-term needs.