Objective
Selecting and qualifying a primary and secondary manufacturing service provider for the transfer of the in-house developed biotech drug candidate, suitable for supplying clinical-grade batches
Outcome
- Identification and qualification of suitable GMP-compliant third party manufacturing services providers and analytical services providers
- Transfer and implementation of the in-house developed drug substance manufacturing process and controls
- Validation of the aseptic fill of the drug product formulation
Writing of the IMPD supporting the use of these products in support of clinical trials, up to and including phase 3 trials and CMC support to regulatory affairs addressing the queries of the Competent Authorities