SeraNovo’s formulations are simple to manufacture and the process is well defined.
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.
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.
- We communicate directly with the GMP facility to ensure a simple process transfer
- Time to complete: 2 weeks
- Deliverable: Production process description document