Medical Consumables and Lab Consumables OEM Manufacturer
Medical Consumables and Lab Consumables OEM Manufacturer
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QC Solutions from Standardization to Customization
Your Trusted Partner For Quality Control Needs

SHENTEK® stands as a leading brand committed to delivering top-tier QC solutions for the biopharmaceutical industry. Our range of standardized and customized quality control products is designed to meet the needs of various cell species and manufacturing processes. We have successfully supported thousands of customers throughout their entire product life cycle, from research and development to IND and BLA filing, production, and release. Our unmatched expertise in designing and validating QC methods empowers customers to tackle even the most challenging projects. 

QC Instruments

SHENTEK offer comprehensive solutions for the QC laboratory, including rHCDpurify® Sample Preparation System, SHENTEK-96S Real-Time PCR, AdvSHENTEK DetectInnova System, Bacteria & Fungi Homogenizer and Vertical Laminar Flow Ultra-clean Workbench, designed to meet customers needs.


Sample Preparation Kits

SHENTEK has developed various sample preparation kits, encompassing host cells, vaccines, and animal-origin residual DNA. With our rHCDpurify Sample Preparation System, customers can efficiently extract residual DNA from various biological samples.


Residual Host Cell DNA Quantitation

SHENTEK® Residual Host Cell DNA Quantitation Kits are based on a highly efficient hot-start PCR reaction system and are tolerant to common PCR inhibitors or interference, ensuring reliable, specific and sensitive quantitation, covering various production cells and vectors, with the lowest end of quantitation at fg/μL DNA level.


Residual Host Cell DNA Size Analysis

SHENTEK® Residual Host Cell DNA Size Analysis Kits are based on qPCR system for various host cells, and are able for detecting the sizes of DNA fragments from < 100 bp, 100‒200 bp, 200‒500 bp, to > 500 bp. The assay performance have been validated by multiple parties. The linear range, precision, limit of quantitation and specificity all comply with the requirements of pharmacopoeia regulations.


Residual Host Cell RNA Quantitation

SHENTEK® Residual Host Cell RNA Quantitation Kits are used to quantitate host cell RNA residues in cell and gene therapy products, covering E. coli cell lines for plasmid production and HEK293T for recombinant vector generation. The kits are prepared with specific pre-designed primers and probes, enable one-step RNA reverse transcription to avoid the contamination risk during reaction.


Targeted Sequence QC Kits

SHENTEK® CAR/TCR Gene Copy Number Quantification Kit is a reliable and accurate quality control test for the detection of transgene copy number in CAR-T cells that are transfected with rHIV-1 lentiviral vectors.


Replication-Competent Virus Quantitation

The replication-competent virus risk is an important biosafety concern for usage of viral vectors. SHENTEK provides replication-competent virus qPCR assay kits for the quality control testing of different replication-defective viral vectors. The tests are designed for master cell banks, working cell banks, end of production cells, bulk harvest, supernatant, and post-transduction cell products.


Adventitious Agent Testing

SHENTEK provides rapid microbiological methods (RMM) for efficient mycoplasma, mycobacteria, bacteria, fungi control of raw materials, in-process samples, conventional pharmaceuticals, biotech & short shelf life products and environmental samples. Through systematic validation in suitability, linearity, specificity, sensitivity, limit of detection, robustness (instrument suitability & matrix effect), and ruggedness, the methods are suitable for a variety of samples as alternative analytical methods in regulatory filing.


Cell Line Characterization

Cell line characterization is a key step to confirm the species and identity, to check for the contamination and to verify the functionality or characteristics. SHENTEK developed an extraction-free method for rapid identification of cell culture species, as well as sensitive detection of cross-contaminations among various species using multiplex PCR-based assay.


Residual Host Cell Protein Quantitation

SHENTEK operates highly efficient animal immune pipelines for polyclonal antibody production that guarantees reliable antibodies with high titer and high recognition across all of the bioprocess HCP populations. SHENTEK developed E.coli (Expression Strain BL21) HCP ELISA kits, E.coli (Cloning Strain K-12 & Alkaline Lysis) HCP ELISA kit, and CHO HCP ELISA kit, etc., which are applicable for HCP quantitation for in-process samples, bulk and final products.


Process-Related Residue Assay

Process-related impurities can impact product safety and critical quality attributes at low concentrations. SHENTEK provides the corresponding quality control solutions for Kanamycin, Bovine Serum Albumin (BSA), Porcine Trypsin & Trypsin-analog and Nonspecific Endonuclease (SMNE), etc. to support process development, monitor batch to batch variations and ensure product release meeting specification limits.


Recommended SHENTEK QC Products
Our unmatched skill in crafting and validating QC approaches enables customers to
tackle even the most demanding projects with confidence.
SHENTEK:QC Solutions to Empower Your Innovations
Your Reliable Partner in Quality Control Solutions
  • SHENTEK is dedicated to providing high-quality QC solutions to the biopharmaceutical industry. Our standardized and customized quality control (QC) products cater to various cell species and manufacturing processes.

  • Our unmatched proficiency in formulating and validating QC assays enables clients to successfully tackle the demanding projects.

  • Whether you need off-the-shelf products or customized solutions, SHENTEK stands as your reliable partner for fulfilling your quality control needs.

SHENTEK:QC Solutions to Empower Your Innovations Play
Application
Applications of Biopharmaceutical Quality Control Products
SHENTEK has pioneered the development of state-of-the-art technological platforms such as the IMBS, HCP, LC-MS, NGS, and PCR platforms, all dedicated to ensuring the utmost quality in our products and services.
Updates
Resources
May 08 2024
The Future of QC Labs: Digitization, Automation, and Online Testing
May 08 2024
Emerging technologies such as advanced analytics, robotics, and automation promise significant rewards for the pharmaceutical industry, including increased speed, compliance, cost savings, and product...
Apr 26 2024
Residual Host-Cell DNA Risk Assessment
Apr 26 2024
Biologics are expressed from the hosts of bacterial, yeast, animal cells, and continuous cell lines. As biological products are produced from a cell substrate, it is inevitable that residual host cel...
Apr 16 2024
The Need and Approach of Host Cell Residual RNA Detection
Apr 16 2024
Plasmid DNA (pDNA) are applied for gene therapy and vaccine development. The purification of DNA plasmids is difficult, because supercoiled pDNA (the product) is quite similar in size and structure to...
Sep 20 2024
Upcoming I SHENTEK invites you to join the Bioprocess International (BPI) 2024
Sep 20 2024
Bioprocess International (BPI) 2024Bioprocess International (BPI) 2024 will be held at the Hynes Convention Center, Boston, USA, from September 23-26, 2024. As a leader in quality control in the bioph...
Jul 15 2024
Upcoming I SHENTEK Invites You to Join the Festival of Biologics 2024
Jul 15 2024
Festival of Biologics 2024The Festival of Biologics 2024 will be held at the San Diego Convention Center, from April 15th-17th. As a leader in quality control in the biopharmaceutical industry, SHENTE...
Jun 07 2024
Upcoming I SHENTEK invites you to join the ASGCT Annual Meeting 2024
Jun 07 2024
ASGCT Annual Meeting 2024The American Society of Gene and Cell Therapy’s (ASGCT) Annual Meeting will be held at the the Baltimore Convention Center, from May 7th - 11th. As a leader in quality contro...
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