Shop All Impurity & Contamination Detection Kits

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

The CaptureSelect™ HSA Ligand Leakage ELISA detects contamination of CaptureSelect™ HSA affinity ligand in HSA or HSA fusion products purified using the CaptureSelect™ Human Albumin affinity matrix. The HSA affinity 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 ELISA provides sensitivity to detect the affinity ligand contamination to 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 HSA Ligand Leakage ELISA kit 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™ KappaXL Ligand Leakage ELISA Kit (Thermo Scientific™)

The CaptureSelect™ KappaXL Ligand Leakage ELISA detects affinity ligand contamination of antibodies or antibody fragments purified using CaptureSelect™ KappaXL 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™ KappaXL 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.

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™ 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 ›

CaptureSelect™ KappaXP Ligand Leakage ELISA (Thermo Scientific™)

The CaptureSelect KappaXP Ligand Leakage ELISA detects affinity ligand contamination of antibodies or antibody fragments purified using CaptureSelect KappaXP Affinity Matrix. The ligand, a 13-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 KappaXP 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 biosimilar and recombinant protein affinity resins and ELISAs ›

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

The CaptureSelect™ FSH Ligand Leakage ELISA detects affinity ligand contamination of FSH purified using CaptureSelect™ FSH 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™ FSH 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.

AAV8 Ligand Leakage CaptureSelect™ ELISA Kit (Thermo Scientific™)

The CaptureSelect™ AAV8 Ligand Leakage ELISA detects affinity ligand contamination of antibodies or antibody fragments purified using POROS™ CaptureSelect™ AAV8 Affinity Resin. In this resin 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 ELISA enables the detection of 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 AAV8 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™ Ig Select Leakage ELISA Kit (Thermo Scientific™)

The CaptureSelect™ IgSelect Leakage ELISA detects IgSelect affinity ligand contamination of human IgG purified using IgSelect affinity resin (GE Healthcare). Even when covalently attached, small amounts of the IgSelect affinity ligand can leach off of the chromatography support and co-elute with the antibody. This ELISA provides sensitivity to detect IgSelect 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 human IgG. The CaptureSelect™ IgSelect 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.

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

The CaptureSelect™ hCG Ligand Leakage ELISA detects contamination of CaptureSelect hCG affinity ligand in human chorionic gonadotropin (hCG) purified using CaptureSelect hCG Affinity Matrix. In this affinity matrix the hCG affinity 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 ELISA enables the detection of 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 hCG Ligand Leakage ELISA kit 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™ Lambda Fab Select Leakage ELISA Kit (Thermo Scientific™)

The CaptureSelect™ LambdaFabSelect Leakage ELISA detects LambdaFabSelect affinity ligand contamination of human Fab fragments or Ig’s with a lambda light chain that have been purified using LambdaFabSelect affinity resin (GE Healthcare). Even when covalently attached, small amounts of the LambdaFabSelect affinity ligand can leach off of the chromatography support and co-elute with the antibody. This ELISA provides sensitivity to detect LambdaFabSelect 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 human immunoglobulins or Fab fragments. The CaptureSelect™ LambdaFabSelect 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™ VII Select Leakage ELISA Kit (Thermo Scientific™)

The CaptureSelect™ VIISelect Leakage ELISA detects VIISelect affinity ligand contamination of human recombinant Factor VII purified using VIISelect affinity resin (GE Healthcare). Even when covalently attached, small amounts of the VIISelect affinity ligand can leach off of the chromatography support and co-elute with the purified product. This ELISA provides sensitivity to detect VIISelect 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 VII and other proteins. The CaptureSelect™ VIISelect 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™ Kappa Select Leakage ELISA Kit (Thermo Scientific™)

The CaptureSelect™ KappaSelect Leakage ELISA detects KappaSelect affinity ligand contamination of human Fab fragments or Ig’s with a kappa light chain that have been purified using KappaSelect affinity resin (GE Healthcare). Even when covalently attached, small amounts of the KappaSelect affinity ligand can leach off of the chromatography support and co-elute with the antibody. This ELISA provides sensitivity to detect KappaSelect 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 human immunoglobulins or fab fragments. The CaptureSelect™ KappaSelect 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™ C-tagXL Ligand Leakage ELISA Kit (Thermo Scientific™)

The CaptureSelect C-tagXL Ligand Leakage ELISA detects affinity ligand contamination of antibodies or antibody fragments purified using CaptureSelect C-tagXL Affinity Matrix. The ligand, a 13 kD recombinant protein, is covalently coupled 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 C-tagXL 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™ IgG-CH1 Ligand Leakage ELISA Kit (Thermo Scientific™)

The CaptureSelect™ IgG-CH1 Ligand Leakage ELISA detects affinity ligand contamination of antibodies or antibody fragments purified using CaptureSelect™ IgG-CH1 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™ IgG-CH1 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.