Biopharmaceutical products from recombinant DNA can be contaminated with components of the host cell system used to manufacture the drug. Even after multiple purification steps, significant levels of those impurities can be present. Although low levels of most contaminants may be inconsequential, patient safety importance requires that they be eliminated or reduced to the lowest levels to avoid problems such as adverse immune reactions. Impurities can have significant cost implications in drug development and manufacture. Failure to identify and remove these impurities early in drug development may lead to reduced drug efficacy or adverse patient reactions that could delay release or kill a promising drug candidate. Reducing contaminates to very low levels necessitates multiple purification steps that reduce product yield.

Recombinant pharmaceutical products can be contaminated by residual host cell proteins (HCPs) or other carry over contaminants. It is essential part of manufacturing of biopharmaceuticals to monitor these contaminants.

Host cell proteins produced by the host cell during cell culturing or fermentation can cause an immune response in patients. Their composition is extremely heterogeneous and dependent on the protein product and down-stream purification procedure used. The level of contaminating host cell proteins in the biopharmaceutical product must be quantitatively measured.

“KRIBIOLISA” is an effort to provide these tools as aid to the biopharmaceutical industry after 2 years of in-house product development. These kits are manufactured by us using contaminants which are generic in nature.

“KRIBIOLISA” is the bioprocess contamination products range from us. These are ELISAs in 96 well format with convenience of break-apart strips.

Key Features
• Priced competitively; available with shorter lead times & good product support.
• ELISA with 8 x 12 break-apart strips
• Simple procedural steps for running the Assay.
• Results available within 3 hours hands-on time.

Our Validation Protocols followed are indicated on a separate page. For individual kit validation details, please view the kit insert or ask us for further details.

All our kits now carry the Gold Quality Ring with 5 stars as a mark of our Quality Assurance.  An assurance from us on the quality of our kits and the vigorous validation and QC protocols they follow before they are released for sale.

*** coming soon