Services

Custom Source Materials

Access to cGMP and cGTP
products for transfusion
and transplant; cGMP for
further manufacture in
development

  • Perinatal tissues
  • Umbilical cord blood
  • Blood components
  • Bone marrow -derived stem cells
  • Apheresis derived progenitor cells
  • Mononuclear cells
  • Donor consenting
Development

Transfer, development and optimization of cGMP-compliant scalable processes

  • Cell therapy process development
  • Cell isolation from tissue source
  • Cell Expansion
  • Scale-up
  • Cryopreservation
  • Downstream purification of cellular products
  • Formulation development
Manufacturing

cGMP-compliant manufacturing of cell-based products

  • Pre-clinical manufacturing
  • Early phase clinical-grade manufacturing
  • Late phase and commercial manufacturing
  • Fill/Finish
  • Quality management system
  • Regulatory guidance
  • Facility designed to support manufacturing compliant with U.S., E.U. and Japanese regulations
Testing

cGXP testing services
(in development)

  • Sterility testing (ID and susceptibility)
  • Viral safety testing
  • Cell characterization
  • Potency testing
  • Cell viability
  • Identity/purity testing
  • Custom assay development
  • Method suitability
  • Lot and final product release testing
  • Plasma, Blood, Cord Blood, Tissue and organ donor safety testing
Biopreservation

Management of cold chain processes for cell banks and final cell products

  • Storage of products in LN2 vapor-phase
  • Validated shipping procedures
  • Continuous temperature monitoring during shipping
  • Storage and distribution
  • Stability testing of cell banks and final cell products