SeraNovo’s formulations are simple to manufacture and the process is well defined.
Phase 1
Method transfer
Following completion of the formulation optimisation program a demo batch is produced in our laboratories and a transfer method is described, which significantly reduces the development time at the GMP facility and ensures rapid and simple process transfer.
Phase 2
Manufacturing process
Due to the simplicity of the manufacturing process and no requirement for non-standard equipment, almost any GMP manufacturing facility can be used for producttion of the formulation.
Additional information
- We communicate directly with the GMP facility to ensure a simple process transfer
- Time to complete: 2 weeks
- Deliverable: Production process description document