Immunogenicity testing measures any adverse immune response generated by a biologic such as reduced efficacy or auto-immune, allergic, and anaphylactic reactions in the body.
Immunogenicity assays during clinical and preclinical studies evaluate the tendency of biologics to produce an immune response in the form of ADAs and NAbs. Immunogenic response against biologics and therapeutic proteins is a common concern for scientists and clinicians focused on drug development. These responses could result in adverse clinical events due to the inactivation of drug therapy for patients. Several factors determine whether any biologic does or does not evoke an immune response, including drug structure, variants, immunogenic status, dosage, route of administration, and genetic profile of treated patients. The overall purpose of immunogenicity study, ADA assay specifically, is to determine whether ADA antibodies are generated and can cause adverse events or loss of efficacy.
A suitably developed ADA assay reliably measures and validates immunogenic responses in a variety of biological matrices for your regulatory filing.
KRISHGEN offers highly specific, high affinity Immunogenicity assays including ADA and NAb assays, to analyze your novel compounds in clinical and preclinical studies
Key Features of our Assays include:
Use of Anti-Idiotypic Antibodies in a sandwich format
Ease of use with the widest range of assays for the therapeutic drugs
Convenient and Competitive Pricing
High Degree of Specificity
Validated with High Precision and Reproducibility
Calibrated against FDA Reference Drug / Innovator Drug
We offer the world’s largest range of assays for Biologics and other Therapeutic Drugs for your Immunogenicity Testing.
Dr Jayaraman D. Lead Scientist, leading CRO companyI have been working with a team from KRISHGEN on an assay development and customization before giving us. The project was complicated and needed technical expertise in immunology. I was very pleased with their technical competence and also mastering immunology and delivering a tough project to us on time. Their rigor, punctuality and expertise have been a recipe for the high standards, I would expect for such project from them. Kudos, Krishgen Team!!!
Mr Ramesh Sravanan, VP-Supply ChainThe expertise and command on the logistics chain including the regulatory guidelines from Krishgen is something we admire. As they often indicate, let us do the supplies, and let your team focus on science … is really something the company works on. Delivering consistently, with less than 1% error or delay consistently is the key to their success.
Dr Keith Stevens, visiting Scientist, Norfolk University, UKTo have a company understand science and work with them, is a pleasure. Krishgen not only sells but understands what it sells in terms of the complex cutting edge sceince.
Mellisa Karlowski, Lead Researcher, east coast US CROThe company is good on understanding its customers, is transparent and speaks science. This makes it easier for us to work with them.
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