Gene Therapy Products and Vaccines
We offer comprehensive non-clinical platforms for gene therapies and vaccines, including siRNA, mRNA, AAV, and oncolytic viruses. Our capabilities span specialized delivery routes—such as subretinal and brain stereotactic injections—and include non-human primate models for translational relevance. These systems support POC validation, challenge studies, pharmacodynamics, and safety evaluation, facilitating the development of next-generation biologics.
Assays Established and Validated for Vaccine Development under GLP
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Test Item
Testing Method
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Pseudovirus neutralizing antibody detection
In vitro cellular method
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Detection of SARS-CoV-2 virus in samples (body fluids, tissues, swabs, etc.)
QPCR
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Detection of anti S protein specific antibodies in serum of mice, rats, and monkeys
ELISA
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Detection of specific antibodies against S-RBD protein in serum of mice, rats, and monkeys
ELISA
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Detection of anti N protein specific antibodies in serum of mice, rats, and monkeys
ELISA
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Detection of anti M protein specific antibodies in serum of mice, rats, and monkeys
ELISA
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Determination of adenovirus content in serum of rats and monkeys
QPCR
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Determination of vaccine mRNA content in serum of rats and monkeys
QPCR
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IL-2, IL-4, IL-5, IL-6, IL-10, IFN-γ, TNF-a and other cytokines (microsamples)
MSD
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IL-2, IL-4, IL-5, IL-6, IL-10, IFN-γ, TNF-a and other cytokines
CBA Flow Cytometry
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CD3, CD4, CD8 and other T cell phenotypes
Flow Cytometry
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Immunoglobulin IgG, IgM, IgA, IgE
ELISA or MSD
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Taxonomy of blood and body fluid cells
Sysmex XN1000 Multifunctional Body Fluid Analyzer
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Biochemistry (89 analytical items)
Hitachi 7180 Automatic Biochemistry Analyzer
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Histopathology, immunohistochemistry
Team of professional veterinarians and pathologists
Research Projects
Accomplished
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30 +
Conducted 30 gene therapy product evaluation projects
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30 +
Supported more than 30 products to entry into the clinical III phase
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Received the world's first clinical approval for a multi-targeted cellular therapy product for solid tumors
