About
SHENTEK® is a brand of standardized and customized quality control solutions that support biopharmaceuticals from research and development through production and release QC. It provides kits, instruments and technical services for the analysis of residual host cell DNA, RNA and protein (HCP), adventitious agents, replication-competent viruses, cell line characterization, process impurities, and qPCR/dPCR.
Note Performance, regulatory compliance and product availability differ from product to product. Please check the individual product documentation before use; if you need any materials, contact us and we will check with the manufacturer.
Products
Product Lines
Residual Host Cell DNA Quantitation
- ResHCD™: qPCR kits by production cell and vector, including CHO · HEK293 · E. coli · Vero · MDCK · MRC-5 · Pichia · Human · Plasmid
- Residual DNA quantitation kits for specific sequences such as E1A · SV40
- Residual host-cell DNA quantitation kits (including 2G/3G)
Residual Host Cell DNA Size Analysis
- DNA size analysis kits for CHO · E. coli · Vero · MDCK · HEK293 · Sf9 · Human and others
- Product line for analysis of the <100 bp, 100–200 bp, 200–500 bp and >500 bp ranges
Residual Host Cell RNA Quantitation
- Residual E. coli RNA Quantitation Kit (2G)
- Residual 293T RNA Quantitation Kit
- RNA sample preparation kits
Sample Preparation
- Residual Host Cell DNA Sample Preparation Kits — complex matrices · manual · automated · vaccines · rapid · animal-derived residual DNA
- Residual Host Cell RNA Sample Preparation Kit
- Virus DNA & RNA Extraction Kit
- Mycoplasma · Mycobacteria · Fungi & Bacteria DNA Extraction Kits
Residual Host Cell Protein (HCP)
- CHO · E. coli · HEK293 · MDCK · Vero · Sf9 · P. pastoris HCP ELISA and antibodies
- One-step ELISA option
- HCP platform · LC-MS · 2D electrophoresis · antibody coverage analysis services
Process Impurity Analysis
- EndoSynX™ Recombinant Cascade Kinetic-Chromogenic Assay (endotoxin)
- PyroSup™ Monocyte Activation Test (MAT) Kit
- DNase I · HSA · Kanamycin · BSA · Porcine Trypsin · Nonspecific Endonuclease ELISA
Adventitious Agent Testing
- MycoSHENTEK® Mycoplasma DNA Detection Kit (2G) and sensitivity reference standards
- Mycobacteria · bacteria · fungi DNA detection
- Virus detection kits for BVDV · PI-3 · REO-3 · MVM · PCV and others
Replication-Competent Virus Quantitation
- Replication-Competent Lentivirus (RCL) Quantitation Kit
- Replication-Competent Retrovirus (RCR) Quantitation Kit
- rcAAV-2/N · rcAAV-5/N Quantitation Kits
Cell Line Characterization
- 10-Species Cell Line Authentication Kit
- Telomerase Assay Kit
- Reverse Transcriptase Assay Kit
- Human IL-6 · IFN-γ ELISA Kits
qPCR · dPCR Reagents
- dPCR mix
- RT-dPCR mix
Instruments
- SHENTEK® 96S Real-time PCR System
- rHCDpurify® Sample Preparation System (automated nucleic acid extraction)
- AdvSHENTEK DetectInnova System (Hubble™)
- AdvSHENTEK Mycoplasma DetectInnova Cassette
How to choose
Product Selection Information
Main Uses
- ELISA quantitation of residual host cell protein (HCP)
- Link to HCP antibody coverage · LC-MS analysis services
Selection Criteria
- Whether there is a kit that matches your production cell line (host)
- Sample matrix and dilution conditions for each process step
- Quantitation range and sensitivity needed
- Whether antibody coverage evaluation is needed
- Technical documents to request: instructions for use · validation data
Confirmed Specifications & Options
- Target hosts: CHO · E. coli · HEK293 · MDCK · Vero
- Target hosts: Sf9 · P. pastoris
- One-step ELISA option
- HCP antibodies
- Analysis services: LC-MS · 2D electrophoresis · antibody coverage
What to Tell Us
- Type of production cell line (host)
- Sample type and process step
- Expected HCP concentration range
- Kit · test method currently in use
- Number of tests per month and documents needed
SHENTEK · QC & Biosafety Testing
Residual Host Cell DNA Quantitation Kits
Main Uses
- qPCR quantitation of residual host cell DNA
- Residual DNA size analysis
- Sample preparation (manual · automated)
Selection Criteria
- Whether there is a kit that matches your production cell line · vector
- Sample preparation method suited to the sample matrix
- Whether DNA size analysis is needed
- Compatibility with the qPCR instrument you have
- Technical documents to request: analytical method validation documents
Confirmed Specifications & Options
- Targets: CHO · HEK293 · E. coli · Vero · MDCK · Pichia
- Targets: E1A · SV40 · MRC-5 · Human · Plasmid
- Kit generations: including 2G · 3G
- Sample preparation: manual kits · rHCDpurify® automated system
- DNA size analysis kits available separately
- Validation documents: based on USP <1225> · EP 2.6.21 · ChP 9101 · ICH Q2 (per the manufacturer)
What to Tell Us
- Production cell line (host) and vector type
- Sample type · matrix · process step
- Model of the qPCR instrument you have
- Kit · sample preparation method currently in use
- Number of tests per month and validation documents needed
Downloads