Mission
Improve health
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Jiangsu East-Mab Biomedical Technology Co., Ltd, established in 2016, is a leading biotechnology company dedicated to providing high-quality recombinant protein raw materials worldwide.
With the support of several well-known investment institutions and hundreds of top clients, East-Mab Bio has successfully transitioned from antibody drug R&D to focusing on recombinant protein raw materials. Today, we primarily offer cell culture proteins, IVD diagnostic proteins, and enzymes for pharmaceutical and diagnostic applications, along with a range of related technical services. Over the past few years, we have invested over $30 million to develop a world-class platform for recombinant protein research, validation, and production. East-Mab Bio is committed to supporting advancements in IVD, cell culture media, cell therapy, organoids, cosmetics, and cultivated meat on a global scale.
- 2016Founded in
- 10000㎡R&D and production space
- 4000㎡GMP-standard workshop
- 1000LMaximum fermentation tank
- 110+Biopharmaceutical background team
- 60+Industrial grade shaker
Jiangsu East-Mab Bio
Suzhou East-Mab Bio
Quality Management
01
Quality Management System Certificate
Certificated with ISO13485, ISO9001, ISO14001 and ISO45001
02
DMF Filing
DMF(FDA) filings for 15+ cell culture proteins
03
GMP Workshop
Operating 4500m² GMP-standard workshop (additional details to follow)
04
Quality Management Documents
Strict quality and production process control
05
Validated analytical methodologies
Cell culture protein raw materials analytical methods:
• Bioactivity: developed nearly 50 cell banks dedicated to testing the bioactivity of various cell culture proteins, with further expansion underway
• Stability Testing: evaluate lot-to-lot consistency and product performance over time
• SDS-PAGE
• HPLC
• UV Spectrophotometry
• Endotoxin Quantification
• Microbial Contamination Testing
• Other Quality Indicators: includes assessment of appearance, hydration, turbidity, content.
IVD diagnostic protein raw materials analytical methods:
• UV Spectrophotometry
• SDS-PAGE
• HPLC
• Colloidal Gold Assay
• LC-MS
• SPR
• Sterility Testing
• Dynamic Chromogenic Assay
• Other analyses are conducted as needed to ensure comprehensive quality control.
Medical & Diagnostic enzyme raw materials analytical methods:
• SDS-PAGE
• UV Spectrophotometry
• HPLC
• Agarose Electrophoresis
• qPCR
• Real-Time
• Other specialized tests are conducted as required for comprehensive quality assurance.
Corporate Culture
PositionProvide high-quality recombinant protein raw materials for the world
DedicationTechnology-Driven, Open Communication, Conscientious and Responsible
History
Transitioned from protein-based drug R&D to a biotechnology company specializing in recombinant protein raw materials.
2016
Jiangsu East-Mab Biomedical Technology Co., Ltd was established to advance the R&D in innovative biological drug pipelines.
2018
Protein R&D platform was essentially established, with laboratory instruments and equipment valued at $2 million installed.
2019
Focused on constructing the recombinant protein platform, and developing product lines for IVD diagnostic proteins and cell culture proteins.
2020
Successfully entered the field of IVD raw materials, with kilogram-level protein production capacity, and deeply engaged in protein structure, expression, purification and other fields
2021
Raised a $5 million investment from professional funding institutions and established a subsidiary in Suzhou, China.
2022
Began to construct a new GMP-standard workshop.
2023
With the mission of "improving life and health", adhering to the values of "focused investment, technology-driven, honest communication, and serious responsibility", we provide higher quality products and services for the global biopharmaceutical and IVD industries.
