As a CMO, Singota has chosen a cross-functional staffing model, spanning the functions of sampling/dispensing, formulation, filling, and finishing. Cross-functional staffing entails cross-training so that each employee can make the most of the skills they bring to the company, while acquiring new skills and perspectives.
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.
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