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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