Abstract
The long-term nature of outsourcing biologics process development and GMP manufacturing over the course of clinical trial development can involve unforeseeable events that could be a source of conflict between the sponsor and the CMO.
A successfully outsourced GMP manufacturing program is built upon a common goal and the management of numerous factors in the complex collaboration between the sponsor and contract manufacturing organization (CMO). The successful collaboration involves a synergistic exchange of each party’s knowledge and experience, combining detailed understanding of the product’s intrinsic properties, experience in process development and manufacturing, and GMP regulatory requirements for manufacturing, toxicology, and clinical trials.
In this article, we present the CMO’s perspective on various potential sources of sponsor–CMO conflicts, preventive actions to circumvent conflicts before they occur, and strategies for resolving conflicts as related to process transfer, development, and GMP manufacturing of biologics.
