Clinical Supply Manufacturing Recources

1. 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.

2. GxP Inventory Solution Improves Clinical IP Efficiency And Compliance 8/8/2023

   Learn how this biopharmaceutical research sponsor was able to centralize and digitalize the processes involved in clinical supply production through distribution using GxP Inventory.

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. 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. 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. Addressing Rare Disease Drug Product Manufacturing Challenges 2/22/2023

   Handling development and manufacturing challenges for orphan drugs requires experience, expertise and scalable technologies, along with a flexible and agile supply chain.

8. Integrating Early-Phase Clinical Supply Manufacturing & Distribution 5/10/2022

   A tablet formulation was a solution when developing a new class of anti-infective medicine, allowing the integration of formulation development, clinical trial material (CTM) manufacturing, and supply and distribution to patients.

9. 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. 

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.