Quality Control

Our QC team works closely with our clients and internal teams to implement robust testing methods.

We understand that testing methods have a critical role in the life-cycle of the product.  Our QC team provides testing support to all cGMP manufacturing programs.

Our QC services include:

  • ICH/cGMP stability programs for clinical products

    • Protocol and Study Development
    • Pull Schedule
    • Accelerated and long-term stability studies
  • Standard cGMP testing for in-process and release performed at Cellipont:

    • Endotoxin
    • Flow Cytometry
    • Cell-based potency assays
    • Replication Verification
    • Cell count and viability
    • Fill Volume
    • Appearance
    • PCR-based analytical assays (coming soon)
  • Analytical method qualification, transfers, and validation
  • Sample Management
  • Environmental Monitoring of GMP facilities
  • Management of Outsourced assays
  • Release testing

How can Cellipont help?

Please send us a note and we’ll get right back to you!