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Assay Service at Antibodies Incorporated

Immunopotency Testing
Immunogenicity Testing

Immunopotency Testing

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Immunopotency Testing - Scientist Pipetting Samples
Immunopotency Testing - Scientist Pipetting Samples
Vaccines of various sorts require testing in animal models to establish potency, dose/response, stability, and even to establish delivery systems. We are well equipped to test your vaccine candidates in animal models. Knowing the importance of establishing a standardized assay during development, we have experience in developing assays and writing GMP/GLP procedures in accordance with regulatory agencies. We will serve you by providing assurance of the potency of your product as well as a measure of stability. Whether you are developing cDNA vectors, subunit, or peptide vaccines, even delivery systems such as liposomes, we can help you with pre- and early-clinical design, testing and studies where monitoring the potency of the vaccine is essential in an animal model. Your regulatory requirements are met through our qualifications.
Part Number Item Description Price
57-842 Immunopotency Testing Inquire

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Immunogenicity Testing

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Immunogenicity Testing - ELISA plate
Immunogenicity Testing - ELISA plate
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

Part Number Item Price
57-841 Immunogenicity Testing Inquire

Prices listed are for customers purchasing in North America.

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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