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Professionalism in products
Dedication to quality

Focusing on the key factors that impact Critical Quality Attributes (CQAs) and advancing the standardized Quality Control (QC) methods

Biotech innovation
Empowers biologics manufacturing

Building platforms and pushing boundaries fuels innovation

Biologics Quality Control Solutions

Biologics Quality Control Solutions  +  Customized Technical Services

Cell Therapy Products

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.

Cell Therapy Products

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.

Gene Therapy 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.

Vaccines for Human Use

The testings that apply to quality vaccine development cover sterility, pyrogen, toxicity, abnormal toxicity, antibiotics residues, impurity residues and etc.

Recombinant Proteins & Therapeutic Antibody

The quality control of recombinant protein products employs appropriate methods for characterization, purity, potency, impurity and other testings.

Biomaterial medical implants and devices

Molecular Biology Techniques offer essential technical support for accurate risk assessment and control of biomaterial-based medical implants and devices.

Biotech-based Small Molecule Drugs

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.

About Us

HZSKBioⓇ is committed to delivering professional products with dedicated quality. With an end-to-end supply chain that cover R&D, production, sales, and technical services, we provide standardized testing kits and customized technical services for biopharmaceutical and biotech companies, CRO/CDMO, research institutions, and 3rd party testing institutions. 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, and dedicated to providing tools that empowers innovations and development of biologics.
More about us

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.

News & Insights

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  • BioCon Asia 2023 ADVANCED CELL & GENE THERAPY(ACGT) CONFERENCE

    2023-09-26

    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.