Providing expert support to the external manufacturing operations department of a Major Pharma during the technology transfer of a blockbuster product from in-house manufacturing to a third party CMO


Oversight of the technology transfer of a blockbuster status injectable product from in-house production to a qualified contract manufacturing organization while changing from a solution in vial presentation to a pre-filled syringe presentation


  • Successful process and in-process controls analytical transfer
  • Definition and qualification of the new specific unit operations, including siliconization, filling precision and visual inspection criteria
  • Complete process validation
  • Source documents for regulatory purposes