Comprehensive and Accelerated Testing Programs for Cell and Gene Therapies

SK pharmteco’s Cell and Gene Therapy Analytical Testing Services are readily available and positions our clients to successfully meet the challenges associated with commercializing cell and gene therapies.  We offer full testing programs that can be customized to specific products and modalities.  A complete package of platform assays meets the full spectrum of global regulatory requirements and are located at a single provider. Consolidating testing labs allows for the acceleration of results and reduced sample volumes required for testing.  By having the platform assays, this significantly speeds the time required for Analytical Implementation and GMP batch release with no wait times. SK pharmteco’s platform assays allow clients a reduced time to transfer methods by leveraging qualifications and validations already performed at SKPT and utilization of our scientific expertise.

Beyond platform assays, custom assay development is also available, with full services for Phase appropriate qualification and validation activities. This comprehensive offering helps to drive down the costs of cell and gene therapies and brings much needed testing capacity to improve access for the patients that need them.

SKPT’s Analytical Services are differentiated and next generation:

  • Full Package of Assays for Identity, Purity, Potency, Safety and Stability
  • Vector Specific Replication Competent Safety Assays & Biosafety Testing
    • rcAAV, RCL, RCA, and custom assays
    • Adventitious Agent Testing
    • Sterility & Mycoplasma
  • Advanced Analytical Characterization Assays
  • Sequencing: Sanger, Illumina and PacBio
  • Rapid Release Methods
  • Full Analytical Development Capabilities
  • Stability Programs
  • Material Science and Raw Material Testing
  • R&D and CGMP Testing

Please contact us to learn how SK pharmteco can advise and recommend phase appropriate testing programs to support your Cell and Gene Therapy projects.

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