Pre-Clinical Development

Our experience in the delivery of cellular therapy products uniquely positions us to assist with the pre-clinical design and development phases of product development.

We incorporate critical design features at the pre-clinical phase to avoid product maturation with fatal or detrimental flaws. Such features include regulatory, manufacturing, financial, medical-relevance, scientific, technical and assessment characteristics.

Our preclinical offering includes the following services:

  • Test method development
  • Method validation
  • Process validation
  • Process optimization and scale-up
  • Equipment qualification
  • SOP development
  • Batch record development
  • Shipping validation

Through our association with device manufacturers, assay development groups, cell therapy companies and clinical investigators we are developing a library of techniques and methods that may contribute to the success of other technologies through cross pollination. Combined with the access to patient materials, our cGMP/cGTP approach adds value to all developing cellular medicine approaches.