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About Us

BRC
BIOTECHNOLOGY

BRC Biotechnology has built comprehensive development and validation capabilities across molecular, microbial, viral, cell, and animal technology platforms, in strict compliance with global pharmacopoeias, regulations, and industry quality standards. Adhering to these rigorous industry quality standards, BRC Biotechnology has achieved a series of prestigious certifications, including the EU GMP Qualified Person (QP) compliance statement, the United States FDA Facility Establishment Identifier (FEI), ISO 9001: 2015 certification, Biosafety Level 2 (BSL-2) accreditation, China Metrology Accreditation (CMA), China National Accreditation Service for Conformity Assessment (CNAS), and more. With years of biosafety testing experience, deep regulatory expertise, and strong innovation capabilities, BRC Biotechnology has delivered high-quality, compliance-driven biosafety testing services to dozens of domestic and international biotech companies. Our services have been instrumental in supporting their products through the regulatory approval processes with the National Medical Products Administration (NMPA), the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and other regulatory bodies for Investigational New Drug (IND) and Biologics License Application (BLA) submissions. As your reliable biotech-service partner on the path to success, we are committed to delivering world-class biosafety services to ensure your products meet the highest standards of quality and safety.
Delivered Tests
6000+
Engaged Clients
100+
Delivered Projects
600+
FDA/EMA Submission Support
20+
BLA Projects
60+
Commercial Projects
40+
Service Centers

Shanghai Testing Service Center

· 6,000 sqm

· GMP Testing Service Center

· Molecular/Microbiology/Virology/Cell Biology/Immunology

· ISO9001/ISO17205 (CNAS)/CMA/BSL-2

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Suzhou Validation & Animal Testing Center

· 10,000 sqm

· GMP Testing Service Center

· Molecular/Microbiology/Virology/Cell Biology/Immunology

· ISO9001/ISO17205 (CNAS)/CMA/BSL-2

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Co-founding Team
Chief Executive Officer
Haiyang LIU Ph.D
PhD in Biochemical Engineering 15+ years experience of biosafety testing in MNC
Dr. Haiyang Liu graduated from the University of Birmingham, UK. He served as Head of Merck BioReliance® China for seven years. With over 15 years of industry experience, he has held commercial and R&D roles at Thermo Fisher and GenScript.
Chief Strategy Officer
Sunny WANG Ph.D
PhD in Bioengineering 15+ years experience of technology management
Dr. Sunny Wang, formerly Head of New Services at Merck BioReliance® APAC, has over 15 years of experience in biopharmaceutical process technology management, specializing in process development for cell and gene therapy products and biosafety testing technology.
Chief Operation Officer
Wei HE Ph.D
PhD in Biochemistry Engineering 15+ years experience of quality management
Dr. Wei He graduated from Jiangnan University with a major in Bioengineering. He previously worked as Head of Quality in Merck BioReliance® China. He also has experience of working as Operation Head in Charles River and Quality Head in BI and AstraZeneca.
Our Partners
Milestone

2024

Jan

• Establishing a One-Stop Service Capability based on Two Testing Centers in Shanghai and Suzhou

Jul

• CNAS was achieved

Dec

• Global Market layout and Business expansion, Successfully Cooperating with the First Order of the Overseas Customer

Dec

• Successful Cases Emerge Vigorously, High-Quality Delivery Wins Market Reputation

2023

Mar

• CMA was achieved

May

• EU BLA Project was Successfully Delivered

Jul

• Pre-A Financing

Aug

• EU GMP QP was achieved. Provide Biosafety Services to Global Customers that comply with EU GMP Standards

• Successfully Obtained FDA FEI Number, Effectively Assisting Global Customers in Complying with International Regulatory Requirements and Meeting FDA Safety Traceability Requirements

2022

Jun

• Joined in Simbaix Park

Jul

• Shanghai Facility Kick-off

Nov

• Opening Ceremony

• ISO 9001: 2015 was achieved

Dec

• BSL-2 was achieved

2024
2023
2022
IMAGINE THE FUTURE
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