CMO Risk Mitigation: From Lab Scale to Manufacturing Scale

Eric SmartBest Practices, Manufacturing

This series of blog posts on CMO risk mitigation has been focused on the challenge of building an effective working relationship with the contractor a pharmaceutical company chooses to manufacture a drug. This third and final post in this series addresses the problem of bridging the gap from the laboratory to the manufacturing floor.

CMO Risk Mitigation: Managing Process Variables

Eric SmartBest Practices, Manufacturing

In the second of this series of three blog posts, the next objective is to identify Critical Process Parameters (CPPs) – the key variables in a production process that affect Critical Quality Attributes.

In sterile product manufacture, CPPs fall into two main categories: Formulation and Fill/Finish

Understand Your Process: A Key to CMO Risk Mitigation

Eric SmartBest Practices, Manufacturing

This post is the first in a series of three on the subject of CMO risk mitigation. Our focus will be to establish methods to reduce project risks when moving from the laboratory to a GMP manufacturing setting.
In these posts we will try to help managers evaluating contract manufacturing to:
-Determine how to work with the CMO to determine critical process parameters;
-Explore strategies to control or eliminate process variables; and
-Learn how to bridge the gap from lab scale to manufacturing scale

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.”