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MANUFACTURING AND PREPARATION

Our company has partnered with Huizhi Heyuan Biotechnology (Suzhou) Co., Ltd. to establish a full-chain GMP manufacturing platform for CGT products spanning plasmids, viral vectors and cells. Equipped with clean-grade production workshops and manufacturing systems, the platform covers the construction of recombinant engineered cell lines and preparation of primary therapeutic CAR-T cells. Stable commercial production is achieved via cell sorting, ex vivo expansion and full-process aseptic control.

Huizhi Heyuan also operates a 3,500 m² animal testing center housing laboratory animal species including mice, dogs, non-human primates, pigs, rabbits and alpacas. The facility supports a complete suite of preclinical studies, such as in vivo pharmacology and efficacy evaluation, repeat-dose toxicology, biodistribution and immunogenicity safety assessment.

We adhere to pharmacopoeia standards and GMP quality control requirements throughout all workflows. Core raw materials feature traceability and scalable high-purity production, meeting the specifications for genetic modification and preclinical research.

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R&D & Manufacturing System

The company has established a three-site industrialization system linking Shenzhen R&D, Kunshan Manufacturing and US Commercial Operations, covering the full value chain of cell and gene therapy products from proof-of-concept to commercial supply.

Shenzhen R&D Center

Located at Weiguang Life Science Park in the core of Guangming Science City, the center focuses on early-stage research and industrial translation of CGT products, sustaining continuous innovation for our technology platform.

Kunshan Process Development Center

Spanning 5,500 square meters, the facility supports full-cycle process development and manufacturing of plasmids, viral vectors and CAR-T cells, with general-grade and SPF-grade animal housing on-site. All core raw materials feature full traceability, supported by comprehensive analytical and quality control systems to guarantee product safety and batch consistency.

US Commercial Center

Situated in North Wales, Pennsylvania, the center oversees overseas business expansion and global partnerships to advance the worldwide rollout of our product pipeline.