Ustekinumab is a human monoclonal antibody. It is directed against interleukin 12and interleukin 23, naturally occurring proteins that regulate the immune system and immune-mediated inflammatory disorders. In two Phase III trials for moderate to severe psoriasis, the longest >76 weeks, ustekinumab was safe and effective. A third Phase III trial, ACCEPT, compared the efficacy and safety of ustekinumab with etanercept in the treatment of moderate to severe plaque psoriasis. This trial found a significantly higher clinical response with ustekinumab over the 12-week study period compared to high-dose etanercept. It also demonstrated the clinical benefit of ustekinumab among patients who failed to respond to etanercept. Ustekinumab is approved in Canada, Europe and the United States to treat moderate to severe plaque psoriasis.
The KRIBIOLISA™ Ustekinumab ELISA is used as an analytical tool for quantitative determination of Ustekinumab in serum, plasma and cell culture supernatant.
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Ustekinumab are pre-coated onto microwells. Samples and standards are pipetted into microwells and human Ustekinumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated anti-Ustekinumab antibody is pipetted and incubated. After washing microwells in order to remove any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color develops proportionally to the amount of Ustekinumab in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.
Dr Jayaraman D. Lead Scientist, leading CRO company
I 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 Chain
The 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, UK
To 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
Mellisa Karlowski, Lead Researcher, east coast US CRO
The company is good on understanding its customers, is transparent and
speaks science. This makes it easier for us to work with them.