December 15, 2019
Development services
  • Autologous or allogeneic cell therapy and tissue engineered products.
  • Optimization and scale up in different culture systems offering various primary packaging.
  • Technology transfer processes.
GMP Manufacturing
  • cGMP-compliant manufacturing: biological material processing, purification, cell culture and biopreservation
  • Multiple suites of varying sizes and flexible design
  • Closed-system bad filling available
  • Quality Systems for global compliance
Quality control services
  • Analytical test methods development and validation
  • Microbial assays
  • Biossays
  • Product characterization
  • Stability studies
Storage and Distribution
  • Product shipping validation
  • Cryopreservation and cell banking of final product under GMP conditions
  • Cold chain expertise. Validated containers with temperature monitoring during transit
Consulting services
  • Facility Design
  • Turnkey projects
  • cGMP Compliance
  • Assay Selection
  • Regulatory Assessment

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