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. 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.
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, the authors will present potential sources of sponsor–CMO conflicts, preventive actions to circumvent conflicts before they occur, and strategies for resolving conflicts as related to process transfer and development, and GMP manufacturing of bulk biologics.Conflict prevention in CMO selection
At this stage, the CMO is responsible for accurately identifying the process steps that are incompatible with its existing facility or incompatible with the level of expertise required for the project. Doing so will ensure that the CMO avoids underperforming. For its part, the sponsor should have a total awareness of what is and is not known about the product to be developed and should be transparent about the state of development of the process, analytics, scales of previous runs, yields for each step, purpose of each process step, which process steps are problematic, and the behavior of the molecule during the process and under storage conditions. The desired quantities of material should be based on requirements for preclinical, clinical, future market needs, technical considerations, such as scale and process performance, characterization, and stability studies; the evaluation of these will require the intervention of both parties. Should incompatibilities exist, the two parties should brainstorm alternative approaches to meet the sponsor's expectations. This often has the added benefit of building trust between the two parties.