rHCD Quantitation Kits
rHCR Quantitation Kits
DNA Size Analysis Kits
Mycoplasma/Mycobacteria Extraction & Detection Kit
Fungi/Bacteria DNA Extraction & Detection Kits
Replication-Competent Virus Quantitation Kits
Reverse Transcriptase Assay Kits
Virus Extraction & Detection Kits
Telomerase Assay kit
Cell Line Authentification Kit
Biologics Quality Control Solutions
Cell Therapy Products
Gene Therapy Products
Vaccines for Human Use
Recombinant Proteins & Therapeutic Antibody
Biomaterial medical implants and devices
Biotech-based Small Molecule Drugs
To ensure the quality of cell-based therapeutic products, it is essential to implement various quality control (QC) methods tailored to the risk characteristics of the products. Specific control measures should be established to address the different bioprocess technologies utilized in the production of these products.
To ensure the quality and safety of gene therapy products, it is crucial to utilize advanced and well-established testing methods. If necessary, a combination of complementary analysis methods should be employed to effectively achieve the testing objectives.
The testings that apply to quality vaccine development cover sterility, pyrogen, toxicity, abnormal toxicity, antibiotics residues, impurity residues and etc.
The quality control of recombinant protein products employs appropriate methods for characterization, purity, potency, impurity and other testings.
Molecular Biology Techniques offer essential technical support for accurate risk assessment and control of biomaterial-based medical implants and devices.
The European Medicines Agency (EMA), the Food and Drug Administration (FDA), and other regulatory bodies require the submission of residue analysis report for the registration of biotech-based small molecule drugs. This requirement guarantees the reliability and stability of bioprocessing, as well as the safety of the final products.
HZSKBIOⓇ is committed to becoming a pioneer of new technologies for quality analysis, a leader of novel testing methods, an advocate of standardization of QC tests.
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Huzhou Shenke Biotechnology Co., Ltd. (HZSKBIOⓇ) is a leading provider of standardized and customized quality control products for the biopharmaceutical industry.We offer high-quality QC solutions throughout the entire supply chain, from R&D to production. HZSKBIOⓇ successfully supported FDA, EMA and NMPA filings for our customers, and has established FDA type II Drug Master Files (DMF) for their regulatory submissions.