SAGE provides project management and technical leadership for the fill/finish activities of a COVID-19 therapeutic.
Scope of Work:
- Performing Due Diligence of multiple CMOs for the selection of suitable manufacturers to perform fill/finish activities
- Negotiating contracts, Quality and Master Service Agreements
- Managing requests and documentation related to the drug product workstream and various teams including Supply Chain, CMC / Regulatory, Analytical, Quality, Packaging and Logistics.
- Coordinating aseptic technique, process, equipment, and components across multiple CMOs to ensure consistency of operations.
- Writing, Reviewing and/or Approving technical documents, including Tech Transfer Protocols, Engineering and GMP Batch Records, Operation and Quality SOPs, CMC modules for regulatory submissions (IND, EUA, BAA, BLA)
- Review and approval of completed batch documentation for lot release
- Coordination and Management of CMO and timelines for efficient Tech Transfer, commercial filling and packaging activities to ensure critical client filing targets were met. Assisted in the resolution of project hurdles and supply of materials in high demand.
SAGE plays an integral role in the commercialization of this COVID-19 therapeutic, successfully supplying finished product to complete Phase III trials.