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Drug Residue and Process Contamination Assays
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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.

Key Features:

ELISA with 8 x 12 break-apart strips

Simple procedural steps for running the Assay

Results available within 3 hours hands-on time

Priced competitively

    Total 46 products.

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