Shop All Impurity & Contamination Detection Kits

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™ 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™ CH1-XL Ligand Leakage ELISA Kit (Thermo Scientific™)

The CaptureSelect CH1-XL Ligand Leakage ELISA Kit detects affinity ligand contamination of antibodies or antibody fragments purified using CaptureSelect CH1-XL 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 CH1-XL Ligand Leakage ELISA Kit can be used as a tool to aid in development of an optimal purification process and in routine quality control of in-process streams and final product.

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

The CaptureSelect™ hGH Ligand Leakage ELISA Kit detects contamination of CaptureSelect hGH affinity ligand in human growth hormone purified using the CaptureSelect hGH affinity matrix. The hGH 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 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 hGH Ligand Leakage ELISA Kit can be used for 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™ 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.

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.

ViralSEQ™ Vesivirus Detection Kit (Applied Biosystems™)

Viral contamination in mammalian product manufacturing presents a serious risk to the manufacturing process, the manufacturing facility, and the integrity of the product. Vesivirus 2117 is an RNA virus that has re-emerged as a potential threat to mammalian cell culture production. To meet the challenge of rapid, specific, and sensitive detection of Vesivirus, Applied Biosystems has developed the first commercially available integrated kit for isolation and detection of Vesivirus from mammalian cell culture samples.

The ViralSEQ™ Vesivirus Detection Assay is a PCR-based test that enables users to quickly isolate and detect Vesivirus 2117 and all other known strains with high sensitivity and specificity. The test utilizes PrepSEQ™ sample preparation magnetic beads to isolate viral RNA from a wide range of sample types, combined with TaqMan®-based technology for sensitive and specific detection of the viral RNA. The kit also includes a proprietary positive control template that helps eliminate the possibility of false positive results arising from inadvertent contamination of test samples with the positive control.
• Detection of known Vesivirus strains
• Rapid time-to-results in less than 5 hours
• TaqMan®-based real-time PCR assay
• Demonstrated sensitivity and specificity
• Proprietary optimized sample preparation for high RNA recovery

Table 1. Exclusion Panel.The ViralSEQ™ Assay has been demonstrated to be specific for Vesivirus and does not detect RNA purified from related and unrelated species and organisms.

Bacillus 2.5 ng Chicken 5 ng
Clostridium 2.5 ng Dog 5 ng
E. coli 2.5 ngHuman 5 ng
Lactoccus 2.5 ngMDCK 5 ng
Shigella 2.5 ngRat 5 ng
Yeast 5 ngCHO 500 ng
  Human RNA 1 µg

CaptureSelect™ GCSFSelect Leakage ELISA Kit (Thermo Scientific™)

The CaptureSelect™ GCSFSelect Leakage ELISA detects IgSelect affinity ligand contamination of human GCSF purified using GCSFSelect 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 GCSFSelect 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 GCSF. The CaptureSelect™ GCSFSelect 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.

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.

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™ Alpha-1 Antitrypsin Select Leakage ELISA Kit (Thermo Scientific™)

The CaptureSelect™ Alpha-1 AntitrypsinSelect Leakage ELISA detects Alpha-1 AntitrypsinSelect affinity ligand contamination of human Alpha-1 antitrypsin (AAT) purified using Alpha-1 Antitrypsin Select affinity resin (GE Healthcare). Even when covalently attached, small amounts of the Alpha-1 Antitrypsin Select affinity ligand can leach off of the chromatography support and co-elute with the purified product. This ELISA provides sensitivity to detect Alpha-1 Antitrypsin Select 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 AAT and other human plasma proteins like immunoglobulins. The CaptureSelect™ Alpha-1 Antitrypsin Select 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.

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 ›

Cell Culture Contamination Detection Kit (Invitrogen™)

The Cell Culture Contamination Detection Kit is a simple and effective procedure for screening tissue cultures for contamination by microorganisms. The kit not only detects contaminants, but it also identifies the contaminant type. Three fluorescent dyes distinctly stain yeast (and other fungi), gram-positive and gram negative bacteria by slide preparation.