Collect Product
Product Details
Product Overview
Pichia pastoris resDNA Quantitation Kit is designed for quantitative detection of residual Pichia pastoris DNA in biopharmaceuticals (Antibodies, Vaccines, etc.). Based on real-time quantitative PCR (qPCR) method, this kit makes the detection of the residual DNA from Pichia pastoris rapid and reliable. The lower limit of quantitation is 3 fg/µL. All procedures are typically in less than 4 hours.
Use the kit after you extract host cell DNA from test samples. To achieve the best performances, resDNA Sample Preparation Kit Ⅱ(Magnetic Beads) (Cat. No. OPA-R024) is recommended for DNA extraction.
Features
- High sensitivity for optimal product safety: LLOD (1 fg/µL) for detection of residue host cell DNA
- High specificity: No cross-reactivity with unrelated DNA
- Validation: ICH Q2(R2) as Validation of Analytical Procedures
- High-quality: This kit is manufactured in ISO 13485 standard facility.
Application
The kit is used for quantitative detection of residual Pichia pastoris DNA in biopharmaceuticals.
For use in quality control/manufacturing process only.
It is for research use only.
Technical Specifications
Attention
If your experimental workflow involves host cell DNA sample preparation, please use the recommended sample preparation kits listed in the table. This ensures that the buffers used during both sample preparation and residual DNA quantitation remain consistent, supporting reliable and accurate results.
Materials Provided
IDComponentsSizeOPA-R017-012×qPCR Master Mix1.0 mL×2OPA-R017-02Pichia Primer & Probe Mix700 μLOPA-R017-03Pichia DNA Control（3ng/μL）100 μLOPA-R017-04Dilution Buffer1.5 mL×3OPA-R017-05DNase/RNase-Free Water1.0 mLACRO Quality Management System
Kunden haben auch angesehen
Data Display
Typical Data
Please refer to DS document for the assay protocol.
Figure 1. High sensitivity and broad dynamic range using the Pichia pastoris resDNA Quantitation Kit. (A) Typical analysis results obtained with Standard 1 (300 pg/μL) to 6 (3 fg/μL). (B) The standard curve of the 10-fold dilution series. PCR efficiency should be 90-110%.
Figure 2. Assay specificity. Standard curves generated using 10-fold serial dilution of Pichia pastoris genomic DNA (included in the kit) in the presence of DNA (CHO, E. coli and HEK293).
User Reviews Publish Comment
Contact Us
Drug Candidate Licensing
