- Immunology products:
- Monoclonal antibodies
- Other Immunoproteins
- Development and validation of immunoassay using potency tests and immunogenicity tests:
- Flow cytometry
3 questions to Claude GAILLARD*, Quality Control Manager
What is a Potency Assay?It is a control method that uses a biological test to analyse the response of a defined dose of a product. The test provides an answer relating to the functional activity of the product or the drug being tested. These tests can includes techniques such as flow cytometry or ELISA.
What is it used for?A Potenty Test is of course essential to validate the quality of a product. This is especially true in biology in which variability is present whatever project. It also enables to carry stability studies that are essential during the initial phases of a clinical trials.
Potenty Test is one of the mainstay of the validations of production batches.
What does Bio Elpida offer in this context?We can have an hand on very early stages, with proposals for innovative in vitro tests meeting the specific quality objectives of a manufactured product. We can also develop tests or, if they exist, transfer technologies until validation of the methods.
This broad range of intervention is possible at Bio Elpida thanks to the multidisciplinary skills of the Quality Control team. It is these skills that enables us to adapt to customer needs and to the development stage of a project.
* After 15 years at the Schering-Plough Immunological Research Laboratory, Mrs. Gaillard then took positions in Quality Control, especially at Génopoïétic Laboratory. She joined Bio Elpida when the company was founded, in 2009.