What Shentek does

Shentek (legal entity: Huzhou Shenke Biotechnology Co., Ltd.) is a privately held Chinese-American biopharmaceutical quality control solutions provider founded in 2012 and dual-headquartered in Huzhou, China and Santa Clara, California. The company sells standardized and customized QC instruments, reagents, kits, and analytical services used by biopharmaceutical manufacturers to test biological products for residual host cell DNA, RNA, and proteins, mycoplasma, mycobacteria, fungi, bacteria, viruses, and process-related impurities.

The product portfolio centers on three QC instruments — the rHCDpurify® automated nucleic acid extraction platform, the SHENTEK® 96S Real-Time PCR System, and the AdvSHENTEK DetectInnova (Hubble™) rapid microbiological method system — supported by an extensive catalog of sample preparation kits, residual DNA quantitation kits covering 20+ cell lines, HCP ELISA kits, replication-competent virus (RCL/RCR/rcAAV) quantitation kits, mycoplasma and mycobacteria detection kits, process impurity assays, and qPCR/dPCR reagents. All products are validated per ICH Q2, USP, EP, and ChP pharmacopoeia regulations, manufactured under ISO 13485:2016, and the instruments comply with FDA 21 CFR Part 11. Performance specifications include femtogram-per-microliter residual DNA sensitivity, 10 CFU/mL mycoplasma LOD, and detection coverage of 180+ Mycoplasma species.

The business model is a direct, enterprise B2B sales motion with quote-based pricing and no publicly disclosed list prices. Revenue is generated through one-time sales of instruments and kits (QC instruments and equipment, diagnostic and detection kits, sample preparation kits) plus professional services revenue from the SHENTEK Testing Center, which operates registered microbiology and PCR laboratories for non-clinical sample testing. The company markets through trade exhibitions, a multilingual website in seven languages, and direct sales engagement targeting biopharmaceutical customers from pre-IND through BLA filing and commercial product release. Ownership and capitalization details, including any institutional shareholders, are not disclosed in the available source material, and the company is led by President Tao Wang, Ph.D.

Name

Shentek

Legal name

Huzhou Shenke Biotechnology Co., Ltd.

Website

https://shentekbio.com

Company type

Private

Founded year

2012

Operating status

Operating

Headcount range

1–10 employees

Short description

Shentek is a privately held Chinese-American biopharmaceutical QC solutions provider, selling instruments, reagents, and analytical services used by biologic manufacturers to detect residual host cell DNA/RNA/proteins, mycoplasma, viruses, and process impurities across pre-IND through commercial production.

Ownership category

akta.pro rank

Product category

Biopharmaceutical Quality Control Reagents and Instruments

NAICS

Analytical Laboratory Instrument Manufacturing (334516), Research and Development in Biotechnology (except Nanobiotechnology) (541714), In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

Services-Commercial Physical & Biological Research (8731), Laboratory Analytical Instruments (3826), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Analytical Development & QC Testing (Release/Stability/Potency) (HLAGAGAF)

akta.pro secondary industries

Gene Therapy Analytical Testing & QC (potency, vg/ddPCR, infectivity, RCL/RCA) (HLAAACAK), Cell Therapy Quality, Analytics & Release Testing (potency, sterility, comparability) (HLAAABAK), Cell-Based & Potency Assays (Bioassays) (HLAGADAH), GMP Quality, Validation & Regulatory Support (GMP/CSV/Qualification) (HLAGAGAL)

Keywords

• Biopharmaceutical QC kits
• Residual host cell DNA
• Mycoplasma detection assays
• QPCR reagent systems
• Adventitious agent testing

Headquarters

HQ city

Santa Clara

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain

Revenue model

1. QC Instruments and Equipment Sales: Sale of QC laboratory instruments including the AdvSHENTEK DetectInnova System, rHCDpurify® Preparation System, and SHENTEK 96S Real-Time PCR System.
2. Diagnostic and Detection Kit Sales: Sale of standardized and customized quality control kits for residual host cell DNA, RNA, protein quantitation, mycoplasma detection, mycobacteria detection, adventitious agent testing, replication-competent virus quantitation, cell line characterization, and process impurity assays.
3. Sample Preparation Kit Sales: Sale of magnetic particle-based sample preparation kits for manual and automated extraction of residual DNA and RNA from various biological matrices.
4. Laboratory Testing Services: SHENTEK Testing Center provides non-clinical sample microorganism-related testing and residual host cell DNA detection services through registered microbiology and PCR laboratories.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Shentek develops, manufactures, and sells biopharmaceutical quality control solutions including QC instruments (automated nucleic acid extraction systems and real-time PCR platforms), sample preparation kits, residual host cell DNA/RNA/protein quantitation kits, mycoplasma and adventitious agent detection kits, replication-competent virus quantitation kits, cell line characterization kits, process impurity assays, qPCR/dPCR reagents, and laboratory testing services. The offerings support biopharmaceutical companies from R&D through IND/BLA filing and commercial product release across recombinant proteins, therapeutic antibodies, vaccines, cell therapies, gene therapies, and biomaterials.

Product overview

SHENTEK is a biopharmaceutical quality control (QC) solution provider offering standardized and customized products across multiple technology platforms. The product portfolio centers on QC instruments including the rHCDpurify® Preparation System (automated nucleic acid extraction), SHENTEK 96S Real-Time PCR System, and AdvSHENTEK DetectInnova System (Hubble) for rapid microbiological methods. Supporting these instruments is a comprehensive range of sample preparation kits covering host cell DNA, RNA, mycoplasma, mycobacteria, fungi/bacteria, and virus extraction. The core assay portfolio includes residual host cell DNA quantitation kits (E. coli, CHO, Vero, HEK293, and 20+ cell lines), residual host cell RNA quantitation kits, residual host cell protein (HCP) ELISA kits, replication-competent virus quantitation kits (RCL/RCR/rcAAV), DNA size analysis kits, cell line characterization kits, adventitious agent testing kits (mycoplasma, mycobacteria, bovine viruses, porcine circovirus), and process impurity assay kits (endotoxin, trypsin, BSA, kanamycin). The products also include qPCR & dPCR reagents. All products are designed for use across the biopharmaceutical product lifecycle from R&D through IND/BLA filing to commercial production release.

Differentiator

Problem solved

Functional benefit

Brands

• SHENTEK®: Primary brand for host cell DNA, RNA and Protein detection kits covering over 20+ cell lines; Cell Line Characterization; Cell Culture Derived Impurity testing; Genetic Safety Testing; Component testing.
• MycoSHENTEK®
• AdvSHENTEK®
• MicroSHENTEK®
• rHCDpurify®
• Hubble™

Products and services

• rHCDpurify® Preparation System Automated nucleic acid extraction platform with built-in optimized and validated procedures for residual host cell, mycoplasma, and mycobacteria sample preparation; offers one-click trace DNA extraction and is compatible with SHENTEK DNA sample preparation kits for biopharmaceutical QC teams.
• SHENTEK® 96S Real-Time PCR System Real-time PCR instrument for QC laboratories providing min 1 copy sensitivity, CV < 1.00% repeatability, 6 fluorescence detection channels, and ±0.1°C temperature accuracy; designed for GMP environments with FDA 21 CFR Part 11 compliance.
• AdvSHENTEK® DetectInnova System (Hubble™) Automated nucleic acid extraction and real-time PCR system for rapid mycoplasma detection offering 2.5-hour turnaround time, less than 5 minutes hands-on time, LOD < 10 CFU/mL, and detection of over 180 species of Mycoplasma, Spiroplasma, and Acholeplasma for biopharmaceutical QC labs.
• AdvSHENTEK® Mycoplasma DetectInnova Cassette Closed disposable cassette containing all necessary reagents for nucleic acid extraction, purification, amplification, and detection of Mycoplasma using magnetic particle separation and real-time fluorescence PCR; used with the AdvSHENTEK DetectInnova System.
• Residual Host Cell DNA Sample Preparation Kits Magnetic particle separation kits for extracting residual DNA from a diverse range of biological products across multiple manufacturing steps, supporting both manual and automated extraction using the rHCDpurify® instrument; variants available for vaccines and animal-origin biomaterials and a 2G formulation for complex bioprocess matrices.
• Residual Host Cell DNA Quantitation Kits qPCR-based kits for quantitation of residual host cell DNA across 20+ cell lines including CHO, E. coli (2G), Vero, HEK293 (3G), NS0/SP2/0, MDCK, Sf9/AcNPV, Hi5/AcNPV, Human (2G), BHK, SV40 LTA/E1A (2G), E1A, E1B, Plasmid (3G), PG13, MRC-5, RDF21, Pichia pastoris, Hansenula polymorpha, Saccharomyces cerevisiae, CV-1, Bovine, Porcine and others; uses hot-start DNA polymerase optimized for inhibitor resistance and dUTP/UNG contamination prevention.
• Residual Host Cell RNA Quantitation Kits Real-time PCR kits for quantitation of residual host cell RNA, including E. coli (2G) and 293T variants with one-step RNA reverse transcription for cell and gene therapy product release.
• Residual Host Cell Protein (HCP) ELISA Kits Sandwich ELISA kits including CHO HCP (one-step ELISA) and E. coli (protein expression strains) HCP for residual host cell protein quantitation with LOQ 1-10 ng/mL, CV<15% precision, 80-120% accuracy, and IMBS-2D&MS orthogonal coverage validation.
• Mycoplasma DNA Detection Kit (2G) Multiplex PCR-based Mycoplasma detection kit enabling identification of more than 200 species of Mycoplasma, Spiroplasma, and Acholeplasma with high sensitivity and specificity validated per pharmacopoeia regulations.
• Mycobacteria DNA Detection Kit DNA detection kit for Mycobacteria contamination with a strain detection limit of 10 CFU/mL and consistent performance across different sample matrices, validated for biopharmaceutical QC use.
• Bovine Virus Multiplex Detection Kit (BVDV / REO-3 / PI-3 / BPV-3 / BAV-3) Multiplex detection kit for five bovine viruses (BVDV, REO-3, PI-3, BPV-3, BAV-3) commonly tested as adventitious agents in biopharmaceutical production using cell substrates with bovine-derived components.
• Porcine Circovirus Type 2 (PCV-2) Detection Kit Detection kit for Porcine Circovirus Type 2, a significant contaminant screened in biopharmaceutical production using porcine-derived components.
• Fungi & Bacteria DNA Detection Kits DNA detection kits for rapid identification of fungi and bacterial contamination in biological products including cell banks, working cell banks, vaccines, and cellular therapeutic products.
• Replication-Competent Virus Quantitation Kits (RCL / RCR / rcAAV) qPCR assay kits including Replication-Competent Lentivirus (RCL), Replication-Competent Retrovirus (RCR), and rcAAV-2/N Quantitation Kits for biosafety testing of lentiviral, retroviral, and AAV vectors used in cell and gene therapy manufacturing.
• Residual Host Cell DNA Size Analysis Kits qPCR-based kits, including the CHO 2G variant, for detecting DNA fragment size distribution (<100 bp, 100-200 bp, 200-500 bp, >500 bp) to assess residual DNA fragmentation in biologics produced in CHO and other host cell lines.
• 10-Species Cell Line Authentication Kit Multiplex PCR-based assay kit for rapid identification of cell culture species and detection of cross-contaminations among cattle, pig, dog, cat, mouse, rat, Chinese hamster, green monkey, rhesus monkey, and human cell lines.
• Telomerase and Reverse Transcriptase Assay Kits Assay kits for measuring telomerase activity and detecting reverse transcriptase activity as part of cell line characterization and contamination verification of cell substrates used in biopharmaceutical production.
• CAR/TCR Transgene Copy Number Quantitation Kit QC test for detection of transgene copy number in CAR-T cells transfected with rHIV-1 lentiviral vectors, used in cell therapy release testing.
• EndoSynX™ Recombinant Cascade Kinetic-Chromogenic Endotoxin Assay Recombinant cascade kinetic-chromogenic assay (EndoSynX™) for endotoxin detection in biopharmaceutical products.
• Porcine Trypsin and BSA ELISA Kits ELISA kits for quantitation of Porcine Trypsin and Bovine Serum Albumin (BSA) residual process impurities in cell culture and biopharmaceutical products to monitor batch-to-batch variations.
• qPCR & dPCR Reagents (dPCR mix, RT-dPCR mix) Digital PCR master mix reagents including dPCR mix for highly sensitive nucleic acid quantitation and RT-dPCR mix for RNA quantitation applications, supplied as standalone reagents for biopharmaceutical QC laboratories.
• SHENTEK Testing Center Laboratory Testing Services Non-clinical sample microorganism-related testing and residual host cell DNA detection services delivered through Shentek's registered microbiology and PCR laboratories under CNAS certification, offered to biopharmaceutical customers as an outsourced alternative to in-house QC testing.

Segments6 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration8 records

Feature6 records

Scale indicators6 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Cytiva: Cytiva (Danaher) supplies bioprocess solutions including filtration, chromatography, and analytical tools for biologics manufacturing — adjacent peer whose QC analytics offerings and consumables portfolio compete with Shentek's bioprocess sample preparation kits.
• Bio-Rad Laboratories: Bio-Rad supplies CFX qPCR instruments (validated with Shentek kits per Shentek documentation), Droplet Digital PCR systems, and a wide range of life-science research and diagnostics kits — overlapping with Shentek's qPCR/dPCR instruments, reagents, and cell-line authentication kits.
• Eurofins Scientific: Eurofins operates a global network of GMP-compliant biologics testing laboratories offering mycoplasma, sterility, viral safety, and residual impurity testing services — directly competitive with Shentek's lab testing services and adjacent to its consumables business.
• Charles River Laboratories: Charles River provides comprehensive biopharma QC services including mycoplasma, adventitious agent, and viral clearance testing through its Biologics Testing Solutions segment — competing with Shentek's CNAS-certified Testing Center laboratory services for similar biopharma customers.
• Molecular Devices (Danaher): Molecular Devices manufactures microplate readers, qPCR systems, and cell-based assay instruments — comparable to Shentek's 96S Real-Time PCR System and ELISA-reading workflows for biopharma QC and cell line characterization.
• MilliporeSigma (Merck KGaA Life Science): MilliporeSigma provides comprehensive bioprocess QC products including residual host cell DNA/protein detection kits, mycoplasma detection assays, and E2E analytics solutions — a broad incumbent competing across most of Shentek's product categories with much deeper global reach.
• Bio-Techne: Bio-Techne's ProteinSimple and diagnostics segments include ELISA kits, qPCR/dPCR reagents, and protein characterization tools overlapping with Shentek's residual protein/DNA quantitation and cell line characterization kits, though Bio-Techne operates across much broader life-science workflows.
• Sartorius: Sartorius' bioprocess solutions division supplies QC testing instruments, cell line authentication services, and consumables for biologics manufacturing — overlapping with Shentek's QC instruments and sample preparation kits in the biopharmaceutical manufacturing workflow.

Direct peers

• Promega Corporation: Promega manufactures molecular biology kits, qPCR/dPCR reagents, and cell-based assays including nucleic acid extraction and quantification — comparable to Shentek's qPCR/dPCR reagents and DNA/RNA extraction kits serving biopharma and academic customers.
• Cygnus Technologies: Part of Maravai LifeSciences, Cygnus is a leading provider of HCP ELISA kits and host cell impurity detection assays — directly comparable to Shentek's HCP ELISA and residual DNA quantitation kits serving biologics manufacturers with similar regulatory-grade QC products.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/huzhou-shenke-biotechnology-co-ltd

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Shentek