Biopharmaceuticals such as therapeutic antibodies and recombinant proteins are produced in genetically engineered host cells.
Host Cells used for recombinant expression are complex systems containing host cell proteins (HCPs) that can contaminate biopharmaceutical products. Failure to sufficiently remove contaminants early in drug development can result in reduced drug efficacy or can elicit an immune response. Therefore, the final biological drugs should be free from host cell protein contaminants & other impurities like Protein A residuals, endogenous proteins etc. to improve the quality, purity, and safety of biopharmaceuticals.
In general, levels up to 10ng residual host cell DNA per dose, depending on the host cell type and the route of administration, and 100 ppm for residual host cell protein are acceptable.Current methods such as HPLC or GC-MS are with sample prep not only complex and expensive, but also difficult and time consuming. ELISAs for these speed up and simplify the analysis without losing accuracy.
If you working in drug discovery, or upstream or downstream bioprocessing, Krishgen offers a range of products to help optimize and monitor product integrity, and maximize yield.
ELISA with 8 x 12 break-apart strips
Simple procedural steps for running the Assay
Results available within 3 hours hands-on time
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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