Shop All Affinity Ligand Leakage Quantitation Kits

resDNASEQ™ Quantitative Vero DNA Kit (Applied Biosystems™)

The resDNASEQ® Quantitative Vero DNA Kit is a quantitative PCR (qPCR)-based system for the detection of host cell DNA from Vero (African Green Monkey) cells, an expression system commonly used for the production of vaccines. Reliable and rapid, the resDNASEQ® system enables sensitive (as low as 1.5 pg DNA/mL test sample) and specific quantitation of Vero cell DNA, typically in less than four hours. This performance helps ensure a high degree of confidence in quantitation data obtained from a broad range of sample types—from in-process samples to final product—whether the sample contains high molecular weight or sheared DNA.

This kit does not include sample preparation reagents—for this, please see resDNASEQ® Quantitative Vero DNA Kit with PrepSEQ® Residual DNA Sample Preparation Kit.

• Highly sensitive quantitation using proven TaqMan® real-time qPCR technology
• Offers consistent performance across the expected range of DNA fragment sizes
• Integrated system includes sample preparation kit, master mix, TaqMan® primer/probe mix, and Vero genomic DNA standard
• Manual and automated sample preparation, optimized for quantitative recovery from complex sample matrices

The resDNASEQ® Quantitative Vero DNA Kit is designed to provide highly sensitive detection of Vero DNA, allowing you to use small sample volumes to help generate accurate results. The broad linear range of TaqMan® real-time qPCR technology allows you to test samples with variable levels of Vero DNA in the same assay, such as in-process samples with higher amounts of DNA or bulk drug substance with very low amounts.

Easy to use, results in under 4 hours
The easy workflow of the resDNASEQ® Quantitative Vero DNA Kit consists of sample preparation, assay setup, and instrument run and data analysis—all of which you can perform typically in under 4 hours. Start by extracting DNA from your in-process purification and drug substance samples. Then perform qPCR analysis to compare the amount of Vero DNA in your test samples to a standard curve generated with known amounts of purified Vero genomic DNA standard. The resDNASEQ® system includes almost everything you need to carry out these steps, from sample preparation kit to master mix to TaqMan® primer/probe mix to Vero genomic DNA standard, as well as step-by-step instructions.

Consistent performance even with fragmented DNA
For accurate quantitation of residual Vero DNA, assay results must be unaffected by the size of the DNA molecules present in the test sample. With the resDNASEQ® system you get consistent assay performance across a range of DNA fragment sizes.

CaptureSelect™ IX Select Leakage ELISA Kit (Thermo Scientific™)

The CaptureSelect™ IXSelect Leakage ELISA detects IXSelect affinity ligand contamination of human Factor IX, purified using IXSelect affinity resin (GE Healthcare). Even when covalently attached, small amounts of the IXSelect affinity ligand can leach off of the chromatography support and co-elute with the purified product. This ELISA provides the sensitivity to detect IXSelect affinity ligand contamination of less than 1 ng/mL. The assay is designed to minimize interference and to provide accurate quantitation in the presence of Factor IX and other proteins. The CaptureSelect™ IXSelect Leakage ELISA can be used as a tool to aid in optimal purification process development and in routine quality control of in-process streams as well as final product.

resDNASEQ™ Quantitative CHO DNA Kit (Applied Biosystems™)

This quantitative PCR (qPCR)-based kit—part of the resDNASEQ® Quantitative CHO DNA System—enables you to detect sub-picogram amounts of residual DNA from the Chinese hamster ovary (CHO) cell line in under 5 hours. The system overcomes the limitations of traditional methods by combining high-recovery PrepSEQ® sample preparation and TaqMan®-based quantitation of residual DNA.

Real-time quantitative PCR kit for highly sensitive residual CHO DNA quantitation
• Easy to use, results in under 5 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 studies

Real-Time PCR for Highly Sensitive Quantitation
The resDNASEQ® Quantitative CHO DNA System provides highly sensitive detection of CHO DNA, allowing you to use small sample volumes to generate accurate results. The broad linear range of TaqMan® technology allows you to test 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, Results in Under 5 Hours
First, you extract DNA from your in-process purification and drug substance samples. Then you perform qPCR to compare DNA amounts in your test samples to a standard curve generated with known amounts of purified CHO cell standard DNA. The easy workflow of the resDNASEQ™ Quantitative CHO DNA System consists of sample preparation, assay setup, and instrument run and data analysis—all of which you can perform in under 5 hours.

Specific to CHO DNA, No Cross-Reactivity With Unrelated DNA
The target of the assay is highly specific, so that it only detects a hamster-specific region of a multicopy genetic element. We selected this region 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 DNA
For 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.

CaptureSelect™ VIII Select Leakage ELISA Kit (Thermo Scientific™)

The CaptureSelect™ VIIISelect Leakage ELISA detects VIIISelect affinity ligand contamination of B domain-depleted recombinant Factor VIII purified using VIIISelect affinity resin (GE Healthcare). Even when covalently attached, small amounts of the VIIISelect affinity ligand can leach off of the chromatography support and co-elute with human Factor VIII. This ELISA provides sensitivity to detect VIIISelect affinity ligand contamination of less than 1 ng/mL. This assay is designed to minimize interference and to provide accurate quantitation in the presence of human Factor VIII. The CaptureSelect™ VIIISelect Leakage ELISA can be used as a tool to aid in optimal purification process development and in routine quality control of in-process streams as well as final product.

resDNASEQ™ Quantitative NS0 DNA Kit with PrepSEQ™ Residual DNA Sample Preparation Kit (Applied Biosystems™)

The resDNASEQ® Quantitative NS0 DNA kit is a quantitative PCR (qPCR)-based system for the detection of host cell DNA from NS0 (murine myeloma) cells, an expression system commonly used for the production of vaccines. Reliable and rapid, the resDNASEQ® system enables sensitive (as low as 1.5 pg DNA/mL test sample) and specific quantitation of NS0 cell DNA, typically in less than 4 hours. This performance helps ensure a high degree of confidence in quantitation data obtained from a broad range of sample types—from in-process samples to final product—whether the sample contains high molecular weight or sheared DNA.

This kit is bundled together with 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. For the quantitation kit alone without the sample preparation kit, please see resDNASEQ® Quantitative NS0 DNA Kit.

• Highly sensitive quantitation using proven TaqMan® real-time qPCR technology
• Consistent performance across the expected range of DNA fragment sizes
• Integrated system includes sample preparation kit, master mix, TaqMan® primer/probe mix, and NS0 genomic DNA standard

The resDNASEQ® Quantitative NS0 DNA Kit is designed to provide highly sensitive detection of NS0 DNA, allowing you to use small sample volumes to generate accurate results. The broad linear range of TaqMan® real-time qPCR technology allows you to test samples with variable levels of NS0 DNA in the same assay, such as in-process samples with higher amounts of DNA or bulk drug substance with very low amounts.

Easy to use, results in under 4 hours
The easy workflow of the resDNASEQ® Quantitative NS0 DNA Kit consists of sample preparation, assay setup, and instrument run and data analysis—all of which you can perform in under 4 hours. Start by extracting DNA from your in-process purification and drug substance samples. Then perform qPCR analysis to compare the amount of NS0 DNA in your test samples to a standard curve generated with known amounts of purified NS0 genomic DNA standard. The resDNASEQ® system includes almost everything you need to carry out these steps, from sample preparation kit to master mix to TaqMan® primer/probe mix to NS0 genomic DNA standard, as well as step-by-step instructions.

Specific to NS0 DNA, no cross-reactivity with unrelated DNA
The target of the assay is highly specific—it only detects a NS0-specific region of a multicopy genetic element. We selected this region using extensive bioinformatic analysis of multiple related and unrelated species.

Consistent performance even with fragmented DNA
For accurate quantitation of residual NS0 DNA, assay results must be unaffected by the size of the DNA molecules present in the test sample. With the resDNASEQ® system you get consistent assay performance across a range of DNA fragment sizes.

CaptureSelect™ IgM Ligand Leakage ELISA Kit (Thermo Scientific™)

The CaptureSelect™ IgM Ligand Leakage ELISA detects affinity ligand contamination of IgM purified using CaptureSelect™ IgM Affinity Matrix. The ligand, a 14 kD recombinant protein, is coupled by multipoint attachment through stable amide bonds to give high chemical stability and low leakage. Even when covalently attached, small amounts of the affinity ligand can leach off of the chromatography support and co-elute with the protein. This sensitive ELISA detects affinity ligand contamination of less than 1 ng/mL. The assay is designed to minimize interference and to provide accurate quantitation even in the presence of the protein of interest. The CaptureSelect™ IgM Ligand Leakage ELISA can be used as a tool to aid in optimal purification process development and in routine quality control of in-process streams as well as final product.

CaptureSelect™ FcXL Ligand Leakage ELISA Kit (Thermo Scientific™)

The CaptureSelect™ FcXL Ligand Leakage ELISA detects affinity ligand contamination of antibodies or antibody fragments purified using CaptureSelect™ FcXL Affinity Matrix. The ligand, a 13 kD recombinant protein, is coupled by multipoint attachment through stable amide bonds to give high chemical stability and low leakage. Even when covalently attached, small amounts of the affinity ligand can leach off of the chromatography support and co-elute with the protein. This sensitive ELISA detects affinity ligand contamination of less than 1 ng/mL. The assay is designed to minimize interference and to provide accurate quantitation even in the presence of the protein of interest. The CaptureSelect™ FcXL Ligand Leakage ELISA can be used as a tool to aid in optimal purification process development and in routine quality control of in-process streams as well as final product.

CaptureSelect™ TSH Ligand Leakage ELISA Kit (Thermo Scientific™)

The CaptureSelect TSH Ligand Leakage ELISA detects affinity ligand contamination of thyroid-stimulating hormone purified using CaptureSelect TSH Affinity Matrix. The ligand, a 14-kD recombinant protein, is covalently coupled for high chemical stability and low leakage. Even when covalently attached, small amounts of the affinity ligand can leach off of the chromatography support and co-elute with the protein. This sensitive ELISA detects affinity-ligand contamination of less than 1 ng/mL. The assay is designed to minimize interference and to provide accurate quantitation even in the presence of the protein of interest. The CaptureSelect TSH Ligand Leakage ELISA can be used as a tool to aid in optimal purification process development and in routine quality control of in-process streams as well as final product.

View other biosimilars and recombinant protein affinity matrix formats ›

resDNASEQ™ Quantitative CHO DNA Kit with PrepSEQ™ Residual DNA Sample Preparation Kit (Applied Biosystems™)

This resDNASEQ® Quantitative CHO DNA kit is a quantitative PCR (qPCR)-based kit—part of the resDNASEQ® Quantitative CHO DNA System—enables you to detect sub-picogram amounts of residual DNA from the Chinese hamster ovary (CHO) cell line in under 5 hours. The system overcomes the limitations of traditional methods by combining high-recovery PrepSEQ™ sample preparation and TaqMan®-based quantitation of residual DNA.