KRISHGEN offers the world’s widest range of bioassays which are CE marked for IVD Use for biomonitoring of biopharmaceuticals. The immunogenicity caused by the production of anti-drug antibodies (ADA) is an important factor, and is an essential component of post marketing surveillance mandated by FDA. Also prolonged periods of treatment may lead to potential ADA in patients. ADA may sometimes, cause neutralization of the molecule, affecting Pharmaco Dynamics (PD) and Pharmaco Kinetics (PK), making the treatment ineffective.
Proper immunogenicity assessment of biologics requires an in-depth understanding of the design of assays to detect anti-drug antibodies, implementation of proper validation procedures, and experience in analysis and interpretation of sample results. KRIBIOLISA KITS have the distinct advantage of using FDA approved Biologics / Biosimilars and Anti-Idiotypic Antibodies which ensures a high degree of specificity, sensitivity and correlation.
Key Features of our Assays include:
High Degree of Specificity
Use of Anti-Idiotypic Antibodies in a sandwich format
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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