Residual DNA detection assays
Our bioprocess quality control solutions are designed to streamline your host cell residual DNA detection workflow, from sample extraction to qPCR quantification. Helping you achieve the purity of your biotherapeutic and CGT products with assays that can demonstrate whether contaminant levels are in compliance with critical quality attributes.
HostDetect CHO PCR DNA Quant Kit
The HostDetect™ CHO PCR DNA Quant Kit is specific for DNA from CHO genome and not subject to detection of human or environment DNA that might be introduced during sample handling.
The reagents utilize sequence-specific primers and TaqMan® probe to amplify the Alu-equivalent gene of CHO genomic DNA for residual host genomic identification. A primer/probe set to detect Internal Control (IC), is also included for monitoring entire process from extraction to real-time PCR. The reagents also use a dUTP/UNG carryover prevention system to avoid contamination of PCR products. For more information, contact: BioprocessQC@revvity.com
Key Highlights:
- Quantify CHO genomic DNA with as little as 0.01 pg per PCR reaction in < 2 hours of PCR
- Internal control detection for process monitoring from sample extraction to PCR
- High specificity: No cross-reactivity with unrelated DNA
- Flexible extracted DNA input volume up to 10 µL per well
- Scalable reaction numbers from 1 to up to 192 per kit
HostDetect HEK293 PCR DNA Quant Kit
The HostDetect™ HEK293 PCR DNA Quant Kit is specific for DNA from HEK293 genome. The reagents utilize sequence-specific primers and TaqMan® probe to amplify the Alu-element of HEK293 genomic DNA for residual host genomic identification. A primer/probe set to detect Internal Control (IC), is also included for monitoring entire process from extraction to real-time PCR. The reagents also use a dUTP/UNG carryover prevention system to avoid contamination of PCR products. For more information, contact: BioprocessQC@revvity.com
Key Highlights:
- Quantify HEK293 genomic DNA with as little as 0.03 pg per PCR reaction in < 2 hours of PCR
- Internal control detection for process monitoring from sample extraction to PCR
- High specificity: No cross-reactivity with unrelated DNA
- Flexible extracted DNA input volume up to 10 µL per well
- Scalable reaction numbers from 1 to up to 192 per kit
HostDetect E.coli PCR DNA Quant Kit
The HostDetect™ E.coli PCR DNA Quant Kit is specific for DNA from E.coli genome. The reagents utilize sequence-specific primers and TaqMan® probe to amplify the 16S ribosomal RNA gene of E.coli genomic DNA for residual host genomic identification. A primer/probe set to detect Internal Control (IC), is also included for monitoring entire process from extraction to real-time PCR. The reagents also use a dUTP/UNG carryover prevention system to avoid contamination of PCR products. For more information, contact: BioprocessQC@revvity.com
Key Highlights:
- Quantify E.coli genomic DNA with as little as 0.03 pg per PCR reaction in < 2 hours of PCR
- Internal control detection for process monitoring from sample extraction to PCR
- High specificity: No cross-reactivity with unrelated DNA
- Flexible extracted DNA input volume up to 10 µL per well
- Scalable reaction numbers from 1 to up to 192 per kit
Host cell protein detection assays
During biotherapeutic manufacturing and production, CHO, HEK 293 and E.coli host cells produce HCP impurities which, if not removed, can induce immunogenicity in individuals or reduce the potency, stability, or effectiveness of a drug. Therefore, to meet regulatory organizations’ guidelines we have developed a range of HCP detection assays to improve your workflows.
HTRF CHO HCP Detection Kit, 500 Assay Points
The CHO Host Cell Protein (HCP) kit measures contaminants originating from the CHO cells used to manufacture therapeutic antibodies. The kit can be used for the quantification of CHO HCP proteins in routine bioprocess operations, from the completely raw harvest material to the final product. The simple and robust procedure benefits from increased throughput compared to ELISA.
AlphaLISA HEK 293 HCP Detection Kit, 100 Assay Points
Human Embryonic Kidney (HEK) 293 is a cell line commonly used for research and biopharmaceutical production. The HEK Host Cell Proteins (HCP) kit is designed to measure contaminants originating from the HEK cells used to manufacture therapeutic antibodies. This kit can be utilized to quantify HEK HCP proteins at various stages, from routine bioprocess operations to crude harvest materials to final products. Our simple procedure and robust assay offer increased throughput compared to ELISA.
Formats
- Our 100 assay point kit allows you to run 100 wells in 96-well format, using a 50 µL reaction volume (5 µL of sample).
- Our 500 assay point kit allows you to run 500 wells in 96-well or 384-well format, using a 50 µL reaction volume (5 µL of sample).
- Our 5,000 assay point kit allows you to run 5,000 wells in 96-well or 384-well format, using a 50 µL reaction volume (5 µL of sample).
Features
- No-wash steps, no separation steps
- ELISA alternative technology
- Sensitive detection
- Broad sample compatibility
- Small sample volume
- Results in less than 4 hours
- Half the time of an ELISA assay
AlphaLISA technology allows the detection of molecules of interest in a no-wash, highly sensitive, quantitative assay. In an AlphaLISA assay, a biotinylated anti-analyte antibody binds to the Streptavidin-coated Donor beads while another anti-analyte antibody is conjugated to AlphaLISA Acceptor beads. In the presence of the analyte, the beads come into close proximity. The excitation of the Donor beads causes the release of singlet oxygen molecules that triggers a cascade of energy transfer in the Acceptor beads, resulting in a sharp peak of light emission at 615 nm.
AlphaLISA CHO HCP Detection Kit, 100 Assay Points
CHO cells are widely used expression hosts for recombinant proteins and are utilized for the generation of monoclonal antibodies. The CHO Host Cell Proteins (HCP) kit is designed to measure contaminants originating from the CHO cells used to manufacture therapeutic antibodies. This kit can be utilized to quantify CHO HCP proteins at various stages, from routine bioprocess operations to crude harvest materials to final products. Our simple procedure and robust assay offer increased throughput compared to ELISA.
Formats:
- Our 100 assay point kit allows you to run 100 wells in 96-well format, using a 50 µL reaction volume (5 µL of sample).
- Our 500 assay point kit allows you to run 500 wells in 96-well or 384-well format, using a 50 µL reaction volume (5 µL of sample).
- Our 5,000 assay point kit allows you to run 5,000 wells in 96-well or 384-well format, using a 50 µL reaction volume (5 µL of sample).
Features:
- No-wash steps, no separation steps
- ELISA alternative technology
- Sensitive detection
- Broad sample compatibility
- Small sample volume
- Results in less than 3 hours
- Half the time of an ELISA assay
AlphaLISA technology allows the detection of molecules of interest in a no-wash, highly sensitive, quantitative assay. In an AlphaLISA assay, a biotinylated anti-analyte antibody binds to the Streptavidin-coated Donor beads while another anti-analyte antibody is conjugated to AlphaLISA Acceptor beads. In the presence of the analyte, the beads come into close proximity. The excitation of the Donor beads causes the release of singlet oxygen molecules that triggers a cascade of energy transfer in the Acceptor beads, resulting in a sharp peak of light emission at 615 nm.
Protein contamination detection technology
To aid rapid protein contamination detection, utilize an automated microfluidic analysis platform that can support FDA 21 CFR Part 11 regulations. By providing quantitative results for contaminants while using minimal sample volumes, the LabChip™ protein characterization system is invaluable in the biopharmaceutical manufacturing workflow by significantly enhancing protein purity assessment and helping you realize higher quality standards.
LabChip GXII Touch HT Protein Characterization System
Fast and reliable automated QC solutions for biotherapeutics
The LabChip® GXII Touch™ protein characterization system offers an automated alternative to traditional methods by streamlining slab gel electrophoresis, while also providing the increased throughput required by biotherapeutics and genomics workflows. This flexible instrument supports multiple assays for characterizing both proteins and nucleic acids.
Benefits:
- Ease of use
- High throughput
- Flexible
- Small footprint
- Cost efficient
- Fast analysis
- Increased efficiency
- Supports testing in a streamlined and reproducible GMP-compliant environment
With the LabChip GXII Touch protein characterization system, analysis can be performed in as few as 42 seconds per sample, delivering data comparable to data obtained using traditional capillary electrophoresis with as much as a 70X increase in throughput. With an easy-to-use touch screen interface, even novice users can run samples quickly.