Clinical Supply Manufacturing Recources

1. 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.

2. Breaking Down Early Small Molecule Development 3/11/2026

   Adopt an integrated development strategy to streamline the path from early development to the clinic, ensuring timely clinical supply while reducing delays, risk, and inefficiencies.

3. 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.

4. 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.

5. 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.

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. 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. 

8. 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.

9. 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.

10. 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.