Sino-Biocan(Shanghai) Biotech Ltd
2nd Floor, Building 15, No.6055, Jinhai Road, Fengxian District, Shanghai
Contact number
021-60890755
Business Department
Name:罗嘉 Luo Jia
Position:全国业务总监
Telephone:86 13901096635
E-mail:luojia@sinobiocan.com
市场与企业策划部
Name:
Position:联系我们
Telephone:
E-mail:info@sinobiocan.com
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.
Factory management
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
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.