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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.