Pichia pastoris Host Cell DNA Residue Detection Kit is used for the quantitative analysis of Pichia pastoris host cell DNA residuce in intermediate samples, semi-finished and finished products of various biological products. This kit adopts Taqman fluorescent probe and the polymerase chain reaction (PCR) method, which has fg level minimum detection limit and can specifically and quickly detect the residual Pichia pastoris cell DNA. The kit needs to be used together with the the Residual DNA Sample Preparation Kit (Cat# 18461ES). Feature Compliance with regulations: the products are fully validated according to the requirements of Chp, USP, ICH, etc., and their performance is in line with Chinese and foreign regulations and standards; Guarantee of quality: the raw materials of the kits are all self-developed, and the qPCR Mix and other enzyme products are produced in an ultra-clean enzyme factory; High sensitivity: the limit of quantification can reach 3 fg/μL level; High precision: high intra-batch repeatability and low inter-batch variation; Strong exclusivity: specific detection of residual DNA in Pichia pastoris cells without interference from other exogenous genomic DNA; Strong anti-interference: add internal control (IC), easy to exclude sample interference, reaction preparation abnormalities and other factors. Application Residual Pichia pastoris Host Cell DNA test in biological products. Specification Sensitivity 3 fg/μL (range 30fg/μL~300pg/μL) Assay Time ~1.5 hours Assay Principle Fluorescent probe qPCR method Required Instruments Real-time fluorescence quantitative PCR system Components Components No. Name 41328ES50-EN 41328ES60-EN 41328-A Pichia pastoris qPCR Mix 0.75 mL 1.5 mL 41328-B Pichia pastoris Primer&Probe Mix 200 μL 400 μL 41328-C DNA Dilution Buffer 1.8 mL×2 1.8 mL×4 41328-D Pichia pastoris DNA Control (30 ng/μL) 25 μL 50 μL 41328-E IC* 50 μL 100 μL *IC：Internal control. Figures Limit of quantification Pichia pastoris DNA was detected at 30 fg/uL, 10 fg/uL, 3 fg/uL, and 1 fg/uL with 10 replicates for each concentration. The results showed that at concentrations of 3 fg/uL and above, the CV was
