CMO / CRO Selection and Management
The selection of a Contract Manufacturing Organization and of Contract Research Organizations is one of the critical decisions a sponsor - engaged in the development of candidate medicinal products - will take. It is a decision which is made early in CMC development and early in the drug development program. The associated request for proposal (RFP) process and contract negotiations (including quality and price) require significant resources, skills and experience.
CMO selection is often binding beyond the direct contractual and financial details e.g. in the case of biologicals, it may not be technically feasible to move manufacturing during development without negating nonclinical and clinical study data or necessitating bridging studies. Regardless of the compound, it is costly to change CMOs. Therefore a first-time-right approach is crucial.
The decision matrix for the selection of a CRO requires careful definition of the service required and identification of associated critical factors e.g. cost, technology, quality, logistics and time-lines. In the case of niche service providers or service providers with exclusive use of proprietary technologies, the options may be limited and require a proactive approach to ensure a successful collaboration. A single CRO may not be skilled in development, validation and routine analysis (in a suitable good practice quality environment). Analytical methods are often developed and validated before being transferred to a different CRO (or CMO) for routine analysis. This complex process requires management of the CROs and experience of the practical aspects of technology transfer.
The CMC consultants at Kinesis Pharma leverage experience with an extensive network of CMOs and CROs to identify potential CMOs which can deliver the required technical know-how, technology and quality, and evaluate proposals independently and objectively on a case-by-case basis.
Once a CMO/CRO is selected, Kinesis Pharma can carefully manage all aspects of the relationship, this may include contract negotiation, (technical) support, and relevant quality documentation (e.g. batch production records (BPRs)) and reporting to agreed timelines.