A full range of RUO and cGMP qualified assays are available to support the Advanced Therapies industry.
The team partners with clients to develop custom assays or tech-transferred assays to demonstrate the safety, purity and potency of advanced therapies.
Custom platforms are available for development, qualification and validation of RUO and cGMP assays.
A variety of assays are performed to verify the advanced therapies product is safe, and no contamination or safety issues are present for the recipient.
A comprehensive range of analytical testing services to characterize advanced therapies products are available.
Development of custom potency assays or tech transfer of client-developed assays is available. Potency determination is necessary for regulatory submission and release of advanced therapies products.
The collaboratively integrated process with our quality team facilitates new testing and new product introduction. Customizable quality processes include phase appropriate and risk-based testing solutions assuring the safety, purity, identification and potency of cell-based products.
