描述
描述
描述
Under cGMP Operation
Recombinant protein
production facility
描述
Facility workshop
The recombinant protein base of BETAGENE® is located in Shanghai FTZ Simbay Park, with a production area of more than 2500 sqm. BETAGENE® has a mature recombinant expression system. Our production base consists of four workshops: fermentation, purification, filling and QC. The filling workshop is equipped with multiple production 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.

BETAGENE® 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.
See our facility

QC

Fermentation

HPLC-MS500L/50L Fermentation


ELISA ReaderLYNX6000


PCR/qPCR Water System

Purity/WFI


PurificationProduction
AKTAVial

2/5/7/10 mL

Prefillable Syringe

1/3/5 mL

Lyophilization

2.6sqm



Fermentation
Purification
500L/50L Dual line
AKTA
LYNX6000
THERMO SCIENTIFIC
QC
HPLC-MS
THERMO SCIENTIFIC
ELISA Reader
BMG
PCR/qPCR
BIORAD
Production
Vial
Prefillable Syringe
1、3、5mL
Lyophilization
2、5、7、10mL
Water System
Purity/WFI
质量区域
制剂车间
纯化车间
发酵车间
Quality Management
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
描述
cGMP蛋白构建及生产服务
  • 1500万支
    水针产能
  • 1000种+
    工程菌种
  • 20年+
    丰富产业经验
上海贝融生物基因工程有限公司拥有极富经验的蛋白质构建工程师团队,具有成熟完备的生物制备技术,提供多种载体的蛋白产品及服务,这些产品可被应用于细胞培养、细胞治疗、生物纯化、体外诊断抗原等领域。我们的技术优势包括包涵体的可溶表达、提取技术优化、构建难以表达的蛋白。我们可提供蛋白表达构建、小试工艺开发、中试工艺及验证试验用蛋白的提供。
描述
描述
WE PERFECT PROTEIN
Ⓒ 上海贝融生物基因工程有限公司