Release Assay
Assess cell and gene therapy products through release assays covering identity, purity, potency, sterility, and dosage, with options for both in-house and customised assay development.
Release assays are performed to verify the quality, safety, and critical attributes of cell therapy products prior to use. ACTRIS supports assay execution under appropriate quality oversight to ensure suitability, reproducibility, accuracy, and sensitivity in alignment with regulatory expectations.
A portfolio of in-house assays is available to assess product attributes such as dosage, identity, purity, potency, sterility, and residual ancillary materials.
For products with unique requirements, ACTRIS can partner with clients to develop, qualify, and implement customised assays tailored to their specific applications.
