Thermo Fisher, A40001518, resDNASEQ™ Quantitative CHO DNA Kits

Name: resDNASEQ™ Quantitative CHO DNA Kits
Brand: Thermo Fisher
SKU: A40001518

Includes: Assay Kit with Sample Preparation, Unit Size: Each, A PCR (qPCR)-based system to quantitate residual CHO DNA using a genomic DNA standard. The test addresses the need to ensure less than 10 ng/dose of host cell DNA is present. This kit is available with or without sample preparation reagents in the form of a PrepSEQ Residual DNA Sample Preparation Kit, which is optimized for highly efficient residual DNA recovery from complex mixtures of proteins, buffers, and salts.

Catalog Number: A40001518

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Category

PCR Cleanup Kits

TagsPCR Equipment and Supplies PCR Supplies Real Time PCR Products Real Time PCR Reagents and Kits

CollectionsThermo Fisher PCR Equipment & Supplies: Instruments, Master Mixes & Plastics Thermo Fisher Clinical Analyzers & Instruments for Diagnostic Labs Thermo Fisher General Lab Supplies for Daily Workflows — Nalgene, Nunc, Samco & Matrix

Description

Includes: Assay Kit with Sample Preparation
Unit Size: Each
This quantitative PCR (qPCR)-based kit, part of the resDNASEQ™ Quantitative CHO DNA system, enables the detection of sub-picogram amounts of residual DNA from the Chinese hamster ovary (CHO) cell line in under five hours. The system overcomes the limitations of traditional methods by combining high-recovery PrepSEQ™ sample preparation and TaqMan™-based quantitation of residual DNA.This kit is specifically designed for the Chinese market and manufactured at our Guangzhou site to enable local biopharmaceutical and biotech companies to leverage a highly sensitive, world-class residual DNA quantitation solution.This kit is available with or without sample preparation reagents in the form of a PrepSEQ Residual DNA Sample Preparation Kit, which is optimized for highly efficient residual DNA recovery from complex mixtures of proteins, buffers, and salts.Features of the resDNASEQ Quantitative CHO DNA Kit include:
• Real-time quantitative PCR kit for highly sensitive residual CHO DNA quantitation
• Easy to use, results in under five hours
• Specific to CHO DNA, no cross-reactivity with unrelated DNA
• Part of an integrated system that includes sample preparation, TaqMan™ assay and master mix, standard DNA, instrument, and software
• Protocol available for automated sample preparation
• Flexible sample throughput allows you to perform rigorous DNA clearance studiesReal-time PCR for highly sensitive quantitationThe resDNASEQ™ Quantitative CHO DNA Kit provides highly sensitive detection of CHO DNA, allowing the use of small sample volumes to generate accurate results. The broad linear range of TaqMan™ technology allows the testing of samples with variable levels of CHO DNA in the same assay, such as in-process samples with higher amounts of DNA or bulk drug substance with very low amounts. Figure 1 demonstrates the range and sensitivity of the assay. Linearity is demonstrated by analysis of CHO cell standard DNA ranging from 0.3 ng to 3 fg.Easy to use with results in under five hoursThe protocol begins with the extraction of DNA from in-process purification and drug substance samples. qPCR is then performed to compare DNA amounts in the test samples to a standard curve generated with known amounts of purified CHO cell standard DNA. The overall workflow consists of sample preparation, assay setup, and instrument run and data analysis—all of which can be performed in under five hours.Specific to CHO DNA with no cross-reactivityThe assay detects a hamster-specific region of a multicopy genetic element. This region was selected using extensive bioinformatic analysis of multiple related and unrelated species. Testing of assay performance confirmed that the assay is specific to hamster DNA and is unaffected by the presence of as much as 100 ng of unrelated DNA in a test sample.Consistent performance even with fragmented DNAFor accurate quantitation of residual CHO DNA, assay results must be unaffected by the size of the DNA molecules present in the test sample. To test the effect of DNA fragment size on assay performance, we fragmented high molecular weight CHO genomic DNA into low molecular weight DNA by sonication. Figure 2 demonstrates that the threshold cycle (Ct) values for the reactions with the sonicated low molecular weight DNA were comparable to those of the undigested high molecular weight DNA. These results demonstrate that consistent performance was obtained with the kit irrespective of DNA molecular weight.

Specifications

General

Amplicon Size	<100 bp
Host Cell	CHO
Includes	Assay Kit with Sample Preparation
No. of Reactions	100 Reactions
Product Line	resDNASEQ, PrepSeq
Quantity	100 reactions
Species	CHO
Detection Method	qPCR
For Use With (Application)	DNA Quantitation
GC-Rich PCR Performance	High
Label or Dye	FAM + VIC
PCR Method	qPCR
Unit Size	Each

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