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Factory overview
Factory overview


Sino-Biocan Biotech (Shanghai) Ltd. is the wholly owned subsidiary of Sino-Biocan, located in Shanghai Lingang Nanqiao Science and Technology City. With a total area of 7600㎡, it includes GMP-grade consumable clean workshop, liquid clean workshop, equipment production workshop, cell & gene therapy process research lab, equipment R&D lab, high level QC center, high level low-temperature and room-temperature warehouse, reaching production scale of 200,000 sets of consumables, 600,000 bottles of liquid reagents and 3,000 sets of equipment per year for cell & gene therapy preparation. In 2024, Sino-Biocan will expand the second-phase production base of more than 14,000㎡, intending to make it a leading production base for cell & gene therapy intelligent tools in China.


Sticking to the concept of “Quality, Integrity, Innovation, Excellence”, Sino-Biocan has obtained ISO9001 and ISO13485 QMS certification, established a scientific and sound business management system, a complete QA system and a perfect after-sales service system, making every contribution to improve technology level in cell therapy and health management.




Production workshop
  • GMP Production Workshop
  • Equipment Production Workshop
  • QC Center
Production Quality Management

Factory management

Quality System

Six systems complying with GMP requirements complement, penetrate and restrict each other, ensuring legal compliance production, controllable process and stable and reliable quality.
  • Quality System

    Quality System

    ISO13485:2016 QMS

    The quality system includes supplier management, product review, deviation and change management, compliant management, defective product management, returns and recalls, validation, etc.

  • Material System

    Material System

    Identification and classification.

    Effectively ensuring material preliminary acceptance, classification, identification, partition storage, incoming inspection, material release and defective material quarantine.

  • Laboratory System

    Laboratory System

    Ensuring matching of personnel and instruments.

    Specific person managing instrument calibration and maintenance, standard and reference material management, validation and verification, stability testing, quality standards and method establishment, sample and material testing, OOS investigation, etc.

  • Facility and Equipment System

    Facility and Equipment System

    Main production equipment and systems need pass 3Q verification to be put into production.

    The facility and equipment system includes equipment management, factory cleaning and maintenance, installation qualification, operation qualification, performance qualification, SOP drafting of equipment use and maintenance, utility system management.

  • Production System

    Production System

    Establishment of good manufacturing practice and process procedures

    Production in strict accordance with process requirements, completing relevant production records (batch production records, cleaning and site-clearing records, equipment utility logs, etc), accomplishing equipment status identification, use and maintenance, completing deviation investigation, etc.

  • Packing and Labeling System

    Packing and Labeling System

    The packing and labeling system includes acceptance, operation and control of packaging and labeling, delivery inspection of labeled and packed products

    Packaging and labeling verification, QA release, etc.

The quality system includes supplier management, product review, deviation and change management, compliant management, defective product management, returns and recalls, validation, etc.