Factory overview - Shanghai Factory - Sino-Biocan(Shanghai) Biotech

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

GMP Production Workshop

The GMP production workshop has reagent and consumable workshops with Class C clean level. It is equipped with independent air-conditioning units to effectively avoid cross contamination and mutual interference. The personnel and materials in the two workshops are separated and personnel shall change their clothes and shoes twice upon enter and exit, to effectively ensure the GMP environment. The reagent workshop is equipment with an automated filling line with annual production capacity of 300,000 bottles of cell culture medium and cryopreservation medium. The consumable workshop is equipped with automated cutting, hot-pressure welding, ultrasonic cleaning, vacuum drying equipments, with annual production capacity of 200,000 sets of disposable cell concentration kit, disposable cell culture kit, disposable cryobag, etc. The production workshop is built in strict accordance with the Good Manufacturing Practice for Medical Devices and ISO13485 standard, complies with Class C clean level of GMP production standards. Standardized and streamlined production management ensures the quality of each product.

Equipment Production Workshop

The equipment production workshop is constructed according to the standards of dust-free workshop of approx. 800㎡, with in and out shoe/clothes changing, temperature and humidity control, electrostatic protection, etc, so as to ensure a clean and controllable production environment. The workshop has 3 assembly lines, each line has mechanical assembly area, electronic assembly area, process inspection area, complete machine assembly area, debugging and aging area, with an annual output of 1200 active devices. The workshop has testing devices like dielectric strength tester, grounding resistance tester, leakage current tester, sound level meter, vibration tester, digital angle ruler, etc. Sino-Biocan establishes quality management system in accordance with ISO13485:2016 standard and produces strictly following Good Manufacturing Practice for Medical Devices, ensuring quality of each product.

QC Center

The QC center is equipped with functional rooms such as positive control room, microbial limit test room, sterility test room, physico-chemical lab, bacterial endotoxin test lab as well as more than 20 kinds of test equipment such as intelligent particle detector, multi-parameter tester, pH meter, conductivity meter, biochemical incubator, turbidity meter, clean bench, bio-safety cabinet, etc. The construction of lab system is built in strict accordance with the Good Manufacturing Practice for Medical Devices and ISO13485:2016 standard, complies with Class C+A clean level of GMP testing standards. It is equipped with independent ventilation air-conditioning system, all the measuring tools are subject to metrological calibration and regular review to ensure authentic and reliable testing results.

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

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

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

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

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

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.