Assay Development
What is assay development?
The development of defined and controlled procedures used during the manufacturing and testing of in-process and final products.
Why is it needed?
Assay development will ensure that in-process and final products are produced per FDA regulations; that they are made with the highest quality materials and appropriate methods; that all procedures are reproducible and that all products are traceable; and that all products are tested appropriately for integrity, safety, identity, stability, sterility, and potency.PDM Core Services
Service 1:
Development of control assays
Service 2:
Development of manufacturing assays
Service 3:
Performing of stabilization assays
What do I need to do?
Please contact the PDM Core for specifics on the program, technology transfer requirements, and individualized service agreements.E-mail inquires, questions, and orders to:
Becky.Rivoire@colostate.edu