QC & Biosafety Testing

QC · Release

These are the kits and instruments needed for release testing and in-process control, and services that carry out tests that are difficult to run yourself. From residual host cell DNA and RNA, HCP, mycoplasma and adventitious agents to lenti-, retro- and AAV vector safety and recombinant endotoxin testing, we provide validation documentation aligned with regulatory standards (USP·EP·ChP).

Product Lines

Residual host cell DNA · RNA quantitation (qPCR)
HCP · process impurity ELISA
Rapid detection of mycoplasma · mycobacteria · adventitious viruses
Vector safety (RCL · RCR · rcAAV · CAR copy number)
Recombinant endotoxin testing · qPCR instruments · automated nucleic acid extraction
Biosafety testing CRO

Brands at This Stage

SHENTEK Exclusive in Korea

Biopharmaceutical QC — residual DNA · RNA · HCP · adventitious agents · vector safety · process impurities

QC & Biosafety Testing

BRC Biotechnology

Biosafety testing CRO and CelerQ residual DNA kits

QC & Biosafety Testing

Product Selection Information

These are the criteria to look at when choosing a product for your application, and the information that is helpful to share when you contact us. Specifications and options list only what has been confirmed.

SHENTEK · QC & Biosafety Testing

HCP ELISA Kits

Ask About HCP ELISA Kits

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

PDF · SHENTEK Full Product Catalog (34p)Guide · Residual Host Cell DNA and HCP Testing Criteria: Where the Numbers Come From and What to Check in Test Methods

SHENTEK · QC & Biosafety Testing

Residual Host Cell DNA Quantitation Kits

Ask About Residual DNA 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

PDF · SHENTEK Full Product Catalog (34p)Guide · Residual Host Cell DNA and HCP Testing Criteria: Where the Numbers Come From and What to Check in Test Methods

SHENTEK

Biopharmaceutical QC — residual DNA · RNA · HCP · adventitious agents · vector safety · process impurities

Brand Details Contact

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)

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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

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Residual Host Cell RNA Quantitation

Residual E. coli RNA Quantitation Kit (2G)
Residual 293T RNA Quantitation Kit
RNA sample preparation kits

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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

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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

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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

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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

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Replication-Competent Virus Quantitation

Replication-Competent Lentivirus (RCL) Quantitation Kit
Replication-Competent Retrovirus (RCR) Quantitation Kit
rcAAV-2/N · rcAAV-5/N Quantitation Kits

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Target Sequence QC

CAR/TCR Transgene Copy Number Quantitation Kit

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Cell Line Characterization

10-Species Cell Line Authentication Kit
Telomerase Assay Kit
Reverse Transcriptase Assay Kit
Human IL-6 · IFN-γ ELISA Kits

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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

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BRC Biotechnology

Biosafety testing CRO and CelerQ residual DNA kits

Brand Details Contact

Testing Services

Antibody drug (mAb · ADC · RDC) testing
Cell and gene therapy (CGT) testing (viral vectors · oncolytic viruses · stem cells · CAR-T/TCR-T · CAR-NK · TIL)
Recombinant protein · vaccine · nucleic acid drug (mRNA · siRNA) testing
Virus removal validation (ICH Q5A(R2)) · molecular biology · microbiology · virology · cell biology · immunology platforms

CelerQ residual DNA quantitation kits (qPCR)

HEK293/T · CHO · Vero · NS0 · MDCK · SF9 · Hi5 · E.coli · Pichia · Hansenula
E1A · E1B · SV40 LTA · Plasmid · Porcine
Residual DNA fragment distribution analysis kits · residual RNA kits

CGT Safety · Sample Preparation

CelerQ CAR/TCR Copy Number Kit
CelerQ RCL Detection Kit
Host Residual DNA Sample Pre-treatment Kit · DNA Cleaner Kit

QC & Biosafety Testing