Shop All Impurity & Contamination Detection Kits

MycoSEQ™ Mycoplasma Detection Kit Applied Biosystems™

The MycoSEQ Mycoplasma Detection Kit is a real-time PCR assay designed and validated to meet the requirements of European Pharmacopeia Chapter 2.6.7. The primers were designed using a proprietary bioinformatics pipeline to detect >90 mycoplasma species with high specificity and no cross-reactivity to closely-related bacterial species. The assay's sensitivity has been demonstrated by internal and external validations to detect 10 cfu/mL or the genomic equivalent of 10 GC/mL as recommended by regulatory guidance.

Real-time PCR provides rapid results, making this assay ideal for in-process testing or part of a microbial risk mitigation strategy across a bioprocess workflow, including cell line characterization, raw material tests, etc. Additionally, it allows for rapid lot release testing across multiple biotherapeutic modalities (e.g., biologics, vaccines, cell therapy products) and has been widely used and accepted by regulatory authorities following the required validation.

Unlike other mycoplasma kits available, the MycoSEQ kit includes a proprietary Discriminatory Positive Control to differentiate a true positive from any potential cross-contamination positives. This is a key feature in avoiding false positive results from mycoplasma controls used during validation or routine testing.

To date, there are more than ten global manufacturers of therapies subject to U.S. Food and Drug Administration, European Medicines Agency, and/or local regulatory agency review that have received regulatory acceptance for accelerated lot release protocols that specify the Thermo Fisher Scientific MycoSEQ method.

MycoSEQ™ Mycoplasma Detection Kit, with PrepSeq™ sample preparation Applied Biosystems™

The MycoSEQ Mycoplasma Detection Kit is a real-time PCR assay designed and validated to meet the requirements of European Pharmacopeia Chapter 2.6.7. The primers were designed using a proprietary bioinformatics pipeline to detect >90 mycoplasma species with high specificity and no cross-reactivity to closely-related bacterial species. The assay's sensitivity has been demonstrated by internal and external validations to detect 10 cfu/mL or the genomic equivalent of 10 GC/mL as recommended by regulatory guidance.

Real-time PCR provides rapid results, making this assay ideal for in-process testing or part of a microbial risk mitigation strategy across a bioprocess workflow, including cell line characterization, raw material tests, etc. Additionally, it allows for rapid lot release testing across multiple biotherapeutic modalities (e.g., biologics, vaccines, cell therapy products) and has been widely used and accepted by regulatory authorities following the required validation.

The PrepSEQ nucleic acid extraction module included with this version of the kit offers a robust and easy workflow to overcome complex matrix challenges to ensure the required sensitivity. Unlike other mycoplasma kits available, the MycoSEQ kit also includes a proprietary Discriminatory Positive Control to differentiate a true positive from any potential cross-contamination positives. This is a key feature in avoiding false positive results from mycoplasma controls used during validation or routine testing.

To date, there are more than ten global manufacturers of therapies subject to U.S. Food and Drug Administration, European Medicines Agency, and/or local regulatory agency review that have received regulatory acceptance for accelerated lot release protocols that specify the Thermo Fisher Scientific MycoSEQ method.

resDNASEQ™ Quantitative Vero DNA Kit with PrepSEQ™ Residual DNA Sample Preparation 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 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 Vero DNA 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

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™ 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™ 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™ 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.

resDNASEQ™ Human Residual DNA Quantitation Kit with PrepSEQ™ Residual DNA Sample Preparation Kit Applied Biosystems™

The resDNASEQ Human Residual DNA Quantitation Kit is a quantitative PCR (qPCR)-based system for the detection of host cell DNA from human cell lines used as expression systems for recombinant proteins. Reliable and rapid, the resDNASEQ system enables sensitive (as low as 15 pg DNA/mL test sample) and specific quantitation of human cell DNA*. 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 Human Residual DNA Quantitation Kit.

• Highly sensitive quantitation using proven TaqMan real-time qPCR technology
• Consistent performance across the expected range of DNA fragment sizes
• Includes master mix, TaqMan primer/probe mix, and human genomic DNA standard

The resDNASEQ Human Residual DNA Quantitation Kit provides highly sensitive detection of human 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 human 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
With the resDNASEQ Human Residual DNA Quantitation Kit you perform qPCR analysis to compare the amount of human DNA in your test samples to a standard curve generated with known amounts of purified human genomic DNA standard. The resDNASEQ kit includes almost everything you need to carry out these steps, from master mix to TaqMan primer/probe mix to human genomic DNA standard, as well as step-by-step instructions.

Consistent performance
For accurate quantitation of residual human 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.

* Due to the high degree of similarity between genomes, DNA from closely-related primate species such as monkey (Vero), chimpanzee, and orangutan are expected be detected by the resDNASEQ Human Quantitation Kit.

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™ 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™ AAV9 Ligand Leakage ELISA Kit Thermo Scientific™

The CaptureSelect™ AAV9 Ligand Leakage ELISA detects affinity ligand contamination of antibodies or antibody fragments purified using POROS™ CaptureSelect™ AAV9 Affinity 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 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™ AAV9 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.

ViralSEQ™ Mouse Minute Virus (MMV) Detection System Applied Biosystems™

The Applied Biosystems ViralSEQ Mouse Minute Virus (MMV) Detection Assay is part of an integrated DNA purification and real-time PCR-based system for rapid, sensitive detection of MMV from a wide range of sample types. Viral DNA is isolated from a sample using the PrepSEQ 1-2-3 Nucleic Acid Extraction Kit (available separately). Highly sensitive and specific detection of the viral DNA is then performed using TaqMan real-time PCR technology. The assay includes a proprietary positive control molecule that eliminates the possibility of a false positive test result arising from inadvertent contamination of the test sample with positive control.

High specificity and rapid time-to-results
The ViralSEQ MMV assay detects the four known strains of MMV: i, p, m, and c, including seven genomic sequences reported in the NCBI database. Table 1 shows the specificity of the ViralSEQ MMV assay and lack of cross-reactivity with unrelated DNA. The assay workflow is simple and delivers results in just under 4 hours (Figure 1).

Streamlined process for surveillance and early detection
The ViralSEQ MMV Detection Assay is part of the Cell Culture Rapid Methods Program, designed to streamline the detection of three common contaminants of mammalian cell culture-based biopharmaceutical manufacturing (Figure 2). The program sets new workflow standards in efficiency and product quality, combining one sample preparation step with real-time PCR-based assays for the detection of mycoplasma, vesivirus, and MMV on one instrument platform.

Reliable results
The ViralSEQ MMV Detection Assay includes an MMV Discriminatory Positive/Extraction Control, which is a plasmid DNA containing the MMV DNA sequence that is recognized by the MMV detection assay (FAM probe). This control (Figure 3) was designed to behave like MMV DNA in both the sample preparation and detection portions of the process. In addition, the control was engineered with an additional VIC probe binding sequence. The presence of both FAM and VIC signal in a PCR reaction can be used to discriminate a positive test result between MMV (FAM) and the control DNA (FAM and VIC). This novel control enables risk-free DNA spike control testing, eliminating the possibility of a false positive test result due to accidental cross-contamination of a test sample with the positive control DNA.

Low-level detection
The ViralSEQ MMV Detection Assay uses proven TaqMan technology for highly sensitivity detection down to 10 copies of MMV genomic DNA per PCR reaction (viral particles equivalent to 0.002 TCID50). Analysis of 10-fold serial dilutions of MMV genomic DNA demonstrates the broad dynamic range and efficiency of the assay (Figures 4 and 5).

Superior sample preparation method
The PrepSEQ 1-2-3 Nucleic Acid Extraction Kit (available separately) helps enable consistent and high percentage recovery of MMV genomic DNA from complex sample types that include CHO cells and bovine serum. Figure 6 shows that the Ct values of DNA extracted from a spiked sample were comparable to an unspiked control that was amplified in the real-time PCR reaction, demonstrating the highly efficient DNA recovery using the PrepSEQ 1-2-3 kit.

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™ tPA Ligand Leakage ELISA Thermo Scientific™

The CaptureSelect tPA Ligand Leakage ELISA detects affinity ligand contamination of antibodies or antibody fragments purified using CaptureSelect tPA 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 tPA 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 ›

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.
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