CMO Tech Transfer
CMO Tech Transfer Management
Vici has overseen well over 50 scale-up and tech transfer operations at third party CMO’s. You need a development team with experience in regulatory requirements, formulation sciences, analytical chemistry, and pharmaceutical manufacturing operations to complete a successful scale-up or tech transfer operation at a dedicated CMO. Many CMO’s are focused on the large-scale manufacturing equipment, its operations, cGMP, which can result in a less-than-thorough understanding of the interplay between the formulation, clinical requirements, regulatory requirements, and the manufacturing process.
All scale-up operations entail technical challenges and troubleshooting is required as part of tech transfer and manufacturing process scale-up. At Vici, we serve all our clients with dedicated focus to make sure the CMO has all the assistance needed for success. This service is especially useful for start-up companies, clinical stage companies, and sometimes small pharma who may not have the required experience or R&D team.
As part of CMO management, we perform the following operations on behalf of the client:
- Provide a request for proposal (RFP) based on a thorough understanding of the formulation, required testing plan, and required manufacturing process
- Recommend CMOs for our clients
- Receive proposals and conduct CMO visits to evaluate capability and arrange for quality audits when required
- Receive proposals and conduct CMO visits to evaluate capability and arrange for quality audits when required
- Receive and review proposals from CMOs for completeness and negotiate pricing on behalf of the client if requested.
- Organize kick-off meetings, schedule, and participate in regular biweekly meetings to ensure progress
- Evaluate sourced raw materials, check for regulatory compliance, and provide input into raw material substitutions when necessary
- Review and approve all batch records, analytical protocols, method validation reports, stability protocols, and stability reports.
- Review all executed batch records and stability reports and flag trend results which may present a long-term concern
- Troubleshoot technical problems that arise at the CMO in conjunction with manufacturing engineers at the CMO.
- Regulatory compilation of all required documents