Sf9 and Baculovirus DNA Residue Detection Kit is used for quantitatively analysing and detecting Sf9 host cell DNA and baculovirus DNA residues in the development and production of a variety of biologics, such as gene therapies, recombinant proteins and vaccines, using the baculovirus-insect cell (Sf9) expression system.

This kit is based on the principle of fluorescence quantitative PCR by probe method, and uses multiplex qPCR method to detect Sf9 and baculovirus residual DNA, respectively. The limit of quantification can be up to 1 fg/μL for Sf9, and the limit of quantification for baculovirus can be up to 7 copies/uL.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 lower limit of quantification (LLOQ) was 1fg/μL for Sf9 and 7copies/uL for AcNPV;High precision: high intra-batch reproducibility CV <10%, small inter-batch variation i.e. intermediate precision CV <15%;
• Strong specificity: specific detection of Sf9 and AcNPV residual DNA without interference from other exogenous genomic DNA;
• Strong anti-interference: the introduction of internal quality control (IC) can exclude sample interference, abnormal reaction preparation and other factors, effectively avoiding false negatives.

Application

Residual Sf9 and Baculovirus DNA test in biological products.

Specification

Components

^*IC：Internal control.

Storage

This product should be stored at -25~-15℃ for 2 years.

Both 41330-A and 41330-B should be stored protected from light.

Figures

Limit of quantification

Sf9 DNA at concentrations of 3 fg/μL, 1 fg/μL, and 0.5 fg/μL, and baculovirus AcNPV DNA at concentrations of 2.12×10¹copies/uL, 7copies/uL, and 3.5copies/uL were detected, with 10 replicates for each concentration, respectively. The results showed that the CV of Sf9 DNA was <20% at concentrations of 1 fg/μL and above, and the CV of baculovirus AcNPV DNA was <20% at concentrations of 7copies/uL and above. Therefore, the limit of quantification in the Sf9 and baculovirus AcNPV DNA residue detection kits was 1 fg/μL for Sf9 and 7copies/uL for baculovirus AcNPV.

Table 1. Limit of quantification (LOQ) assay results for Sf9 and baculovirus AcNPV DNA

Documents：

Safety Data Sheet

Manuals