Technology Transfer

pharmaceutical manufacturingAs an increasing amount of technology transfers are characterized by a loss of quality or continuity from the product’s original purity, there is an essential value to be placed on requiring a full understanding of the transfer at hand from CMOs.  At Sterling, we offer an understanding that our clients expect speed and efficiency throughout the formulation process, but without comprising quality.

Whether you are looking for a new manufacturer or your current manufacturer cannot accommodate your needs, Sterling’s capacity to handle the molecule from concept to commercialization all in one location provides our clients with the competency to address downstream complications quick. Ultimately, providing clients with a single source to gather continuous feedback, address potential concerns, and all while making the technology transfer process manageable for our clients

Our technology transfer experts provide in-depth experience surrounding:

  • Site Transfer
  • Equipment Selection and Validation IQ, OQ and PQ
  • Existing Process Optimizations (Lean and Six Sigma)
  • Batch Record Development
  • Validation Protocol Preparation and Execution
  • SOP Development and writing
  • Alternate Raw Material Evaluations and Reformulations
  • In-Plant Troubleshooting and Investigations
  • Scale Up Assistance from feasibility to commercialization