A variety of proteins and pDNA which are used as therapeutic agents in humans and animals are produced through recombinant expression in Pichia Pastoris. The manufacturing and purification process of these products tends to leave the potential for contamination by Host Cell Proteins (HCPs) from P.pastoris which may result in adverse toxic or immunological reactions that ultimately affect the efficacy of the therapeutic agent. The simple, objective and semi-quantitative ELISA is a highly sensitive method that aids in purification process development, process control, quality control and product release testing optimally.
Intended Use: This generic kit is intended in determining the presence of Pichia Pastoris Host Cell Protein contamination in various products that are manufactured through recombinant expression in Pichia Pastoris. The kit has been validated successfully for testing of in process and final product HCPs in variety of products regardless of growth and purification process. The Pichia Pastoris is for research use only. Not for diagnostic or therapeutic procedures.
The kit uses a sandwich ELISA format to quantify the target cytokine between two layers of antibodies (i.e. capture and detection antibody). The cytokine to be measured contains at least two antigenic epitope capable of binding to antibody, since at least two antibodies act in the sandwich. The advantage of Sandwich ELISA is that the sample does not have to be purified before analysis, and the assay can be very sensitive upto pg/ml levels (more sensitive than direct or indirect ELISA). A highly efficient blocking and stabilizing proprietary solution is used in the kit. All KRISHGEN cytokine ELISA kits are optimized to give the best possible noise:signal ratios.
KRISHGEN BIOSYSTEMS is a leading manufacturer of immunoassay kits including ELISA. KRISHGEN has over 200 publications and citations to its credit which speaks of its quality and accuracy. Leaders in many areas of research, ELISAs manufactured by KRISHGEN are used for quality research and reproducibility at competitive prices. Diverse product range includes ELISA for diagnostics, cytokines, biopharmaceuticals, HCP, downstream contamination, PK studies for Mabs, immunogenicity, vaccine, animal health testing, plant pathology, GMO and food safety.
ELISA 96 wells
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