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Immunogenicity is a measure of the immune response to a therapeutic drug. It is a very relevant problem affecting the use of therapeutic protein drugs. The development of anti-drug antibodies can cause allergic or anaphylactic reactions, reduction in efficacy, and/or induction of autoimmunity. In the wake of such effects observed in the clinical trial of earlier protein therapeutics, (REFS), the FDA and responsible pharmaceutical companies are insisting that immunogenicity testing become an integral part of protein drug development. Antibodies Incorporated offers qualitative and quantitative assays for detection of anti-drug antibodies. We have experience in developing assays and writing GMP/GLP procedures acceptable to regulatory agencies. We are well equipped to test your drug candidates in animal models from mouse to non-human primate in order to accelerate clinical trials. Our ISO13485 certification by BSI assures you of the ongoing quality of our work.
Our services include:
• Production of a appropriate positive control antiserum
• Purification of reference standard
• Development of bridging or direct ELISA assays for detection of anti-drug antibodies
• Immunodepletion analysis
• Antibody isotyping
Antibodies Incorporated is qualified by
Antibodies Incorporated is qualified by:
ISO 13485 Accreditation (Registration No. FM 61237)
cGMP, GLP
NIH-assurance (OLAW A4064-01)
USDA registration (93-R-B-0202)
FDA registered Device Manufacturer (2914537)
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