resDetect™ Pichia pastoris resDNA Quantitation Kit (qPCR)

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

1. High sensitivity for optimal product safety: LLOD (1 fg/µL) for detection of residue host cell DNA
2. High specificity: No cross-reactivity with unrelated DNA
3. Validation: ICH Q2(R2) as Validation of Analytical Procedures
4. 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

ACRO Quality Management System

1. QMS(ISO, GMP)
2. Quality Advantages
3. Quality Control Process