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描述
描述
under cGMP standard
Recombinant protein facility
The recombinant protein base of HEROSTEM® is located in Shanghai FTZ Simbay Park, with a production area of more than 2500 sqm. HEROSTEM® has a mature recombinant expression system. Our production base consists of four workshops: fermentation, purification, filling and QC. The filling workshop is equipped with three lines: vials, pre-fillable syringe and lyophilized powder. The purification area has C+B+A control levels, which meets the scale of drug pilot test at the same time.

HEROSTEM® provides fast, high-quality and professional GMP grade cytokines, enzyme and protein reagents, as well as protein customization and drug development services for domestic and foreign biopharmaceutical companies and scientific research institutions. These products can be used in cell culture, cell and gene therapy, antibody purification, vaccine preparation, in vitro diagnosis, cosmetics and medical devices. We have established strict QC process and thorough customer service and confidentiality control system to ensure that we can provide customers with high-quality products and top-level services.
描述
车间区域设置
See our facilities
Fermentation
Purification
500L/50L
AKTA
LYNX6000
QC
HPLC-MS
THERMO SCIENTIFIC
Multiskan Spectrum
BMG
PCR/qPCR
BIORAD
Filling
Vial
Pre-fillable syringe
1、3、5mL
Lyophilizer
2、5、7、10mL
Water system
Purity / WFI

QC

Fermentation

HPLC-MS500L/50L fermentation


ELISA readerLYNX6000


PCR/qPCR


PurificationProduction
AKTAVial line

2/5/7/10 mL

Prefillable Syringe line

1/3/5 mL

Lyophilization line

2.6sqm


QC area
Filling
Purification
Fermentation
Strict QA system
We have established cGMP standards, and the production facility complies with ISO9001 and ISO13485, which allow us to provide customers with consistent, safe and traceable GMP protein. QA team comprises on-site QA, document QA and verification QA, and QC comprises basic physicochemical and microbiological teams. Meanwhile, a complete and auditable documenting system is available for further inspection and auditing.
描述
cGMP recombinant protein 
manufacturing service
1200+
engineering bacteria
20 years
production history
15,000,000 vials
production capacity