Developmental research to demonstrate ADCC activity of new therapies
Research type
Research Study
Full title
Developmental research to demonstrate the Antibody-Dependent Cell-mediated Cytotoxicity (ADCC) activity of new monoclonal antibody-based therapeutics.
IRAS ID
268823
Contact name
Sarah Nelis
Contact email
Sponsor organisation
Sartorius Stedim Biooutsource
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
Sartorius Stedim Biooutsource (SSBio) is a contract testing organisation (CTO) who specialise in analytical testing services to global biopharmaceutical researchers, developers and manufacturers. They offer a range of biological, physicochemical, and structural analyses of biologic drugs, carried out by a team of scientists who have extensive knowledge in analytical testing. Over the years, SSBio have worked to build extensive technical and regulatory expertise so that they can successfully support organisations in their development and commercialisation of innovative biotherapeutic products.
A specialist area of SSBio is in cell-based bioassays for monoclonal antibody (mAb) therapeutics. mAb-based therapeutics are revolutionising the treatment of not only cancer, but many other diseases including inflammatory and autoimmune disease.
The scientific team at SSBio can support development, optimisation, qualification and validation of the critical bioassays from simple primary potency measurements through to full characterisation of the biological activity of a biological molecule. SSBio have expertise in methods to measure recruitment of effector functions, induction or inhibition of a variety of secondary and tertiary activities, and antibody internalization. SSBio provides a complementary range of binding assays, and a full suite of analytical physicochemistry tests to ensure a total solution for the characterisation of biological therapeutics.REC name
HSC REC A
REC reference
19/NI/0138
Date of REC Opinion
2 Jul 2019
REC opinion
Favourable Opinion