Approach to Simplifying Aseptic Contract Manufacturing

Eric SmartInnovation, Manufacturing

Anyone responsible for the management of the supply chain to support a pharmaceutical or biologic clinical trial can appreciate the challenges associated with an unexpected or otherwise urgent need to produce clinical drug product. Many factors can conspire to make a rapid response to such an urgent supply situation challenging. This article is the first in a series that describes some of the challenges and solutions available to pharmaceutical/biotech companies and their supply chain partners in the CDMO realm to ensure that critical clinical supply materials are ready when they are needed.

Real-Time Monitoring

Travis HudsonInnovation, Supply Chain Management

We can utilize technology to track the status of online purchases or the current location of our vehicles, smartphones, and even friends and family members. It would make sense then that we would want to take advantage of these same types of technologies as it pertains to the risk mitigation of our sensitive and high value pharmaceutical shipments.

Adaptive Clinical Trials and New Solutions

William PowersInnovation, Manufacturing

Adaptive Clinical Trials

Among the key sources of delay in the development process is the length of the clinical trial process. In recent years, the FDA has allowed some pharmaceutical companies to mitigate these risks, and costs, by approving testing through what are called “Adaptive Clinical Trials.”