Manufacturing
Building Excellence Across Our Platforms.
At JY BioMed, excellence in manufacturing and quality is fundamental to advancing our innovative cell therapies, exosome therapeutics, and targeted biologics. We are committed to developing scalable, reproducible, and compliant processes that support our transition from research through early clinical development. Our manufacturing strategy integrates robust quality systems, strategic CDMO partnerships, and regulatory-grade documentation across all product platforms, ensuring consistency and integrity at every stage.
Capabilities
Our platforms under development — including gamma delta T cell therapies, natural killer (NK) cell therapies, dendritic cell therapies, mesenchymal stem cell (MSC) and exosome products, and antibody-drug conjugates (ADCs) — are manufactured through collaborations with qualified CDMOs that meet Good Tissue Practice (GTP) or Good Manufacturing Practice (GMP) standards.
Key manufacturing partners include:
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Hexun Biosciences – GTP-compliant manufacturing of clinical-grade cell therapies and exosome products
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3D Global Biotech – Bioprocessing and expansion technologies for exosomes and cell products
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Mycenax Biotech – GMP-certified manufacturing of biologics and ADC conjugation, formulation, and fill-finish services
All manufacturing activities are performed under documented processes designed to support future regulatory submissions to TFDA, FDA, EMA, and PMDA authorities.
Principles
At JY BioMed, our manufacturing approach is built upon four core principles:
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Scalability: Development of robust, standardized processes capable of scaling from preclinical research to early clinical trials.
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Reproducibility: Implementation of validated protocols and rigorous in-process controls to ensure batch-to-batch consistency.
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Compliance: Adherence to GTP and GMP standards, aligned with global regulatory expectations for cell therapies, exosomes, and biologics.
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Traceability: Full lifecycle documentation and chain-of-custody tracking from source material to final investigational product release.
Regulatory Disclaimer
All JY BioMed manufacturing activities are conducted for investigational and preclinical purposes unless otherwise authorized by relevant regulatory agencies. Products described are not yet approved for clinical or commercial use.