Cefety Bioscience (Suzhou) Co., Ltd.

Founded in Suzhou, Xiangcheng District

Laboratory design and construction initiated for IND&BLA testing

Laboratory construction completed

Laboratory commissioning and equipment verification completed

Officially began service for external clients

ISO 9001 certification obtained

Received CMA certification

Received official IND approval in USA

Received official IND approval in China

Awarded CNAS certification

Passed U.S. FDA on-site audit

Submitted all test methods, SOPs, and verification reports to the CDE - approved with no objections.

Cefety Bioscience Co., Ltd., established in 2020, is a global provider of biosafety and customized viral testing services for the biopharmaceutical industry.

We serve companies and institutions worldwide, operating in strict compliance with international regulatory standards, including those from China, the United States, Europe, and other major regions.

Our expertise spans hundreds of projects, playing a key role in securing IND and BLA approvals across China, the U.S., Australia, and New Zealand.

We've passed audits and on-site inspections by EU Qualified Persons (QPs) and China's National Medical Products Administration (NMPA), and hold certifications from:
● CMA (China Inspection Body and Laboratory Mandatory Approval)
● CNAS (China National Accreditation Service for Conformity Assessment)
● ISO 9001
● FDA FEI Registration

By strictly adhering to global pharmacopoeias and regulatory frameworks, we ensure data integrity, authenticity, and traceability across all testing.
Our evaluation system supports the quality assessment of Biologics, Cell And Gene Therapies, Nucleic Acid Drugs, and Vaccines, in line with international standards.

Quality Assurance You Can Trust, Globally Aligned

Cefety Bioscience operates a robust quality management system that meets internationally recognized standards, ensuring regulatory compliance, data integrity, and total traceability across all projects.

Our Quality Commitment Includes:

● Certification under CMA, CNAS, and ISO 9001

● Compliance with Chinese and U.S. GLP/GMP regulations

● No-cost audits available in multiple countries

● A fully independent quality department overseeing all testing

● Rigorous validation of methods, test plans, raw data, and reports

● End-to-end traceability and documentation verification

● Expert technical support for IND/BLA applications

Establishing a cell or virus bank is a key step in GMP manufacturing - and contamination at this stage can seriously impact product quality and patient safety.

Cefety Bioscience provides comprehensive testing to ensure regulatory compliance and product integrity, including:

● Cell bank and virus bank characterization

● Intermediate product release testing

All testing is conducted in accordance with:

● Chinese, U.S., and European Pharmacopoeias

● U.S. 9 CFR, FDA PTC (1993/1997/2010)

● ICH Q5A and other global standards

Our validated methods and rigorous quality control ensure accurate, compliant results that support safe, effective biologics development.

Viral clearance validation is performed in specialized labs, independent from the production site, to ensure that virus inactivation and removal steps are effective and compliant.

In this process, model viruses are spiked into raw materials or intermediates at a reduced scale to simulate actual manufacturing conditions. The remaining virus levels are measured post-treatment to confirm the effectiveness of clearance steps.

Because this validation requires high-purity, high-titer viruses, any compromise in virus quality may affect the reliability of process validation.

Cefety Bioscience supports clients in validating key virus inactivation and removal methods, including:

● Low pH treatment

● Solvent/detergent inactivation

● Chromatography

● Nanofiltration

Cefety Bioscience operates a dedicated virus testing center covering 2,400 square meters, equipped with specialized BSL-2 certified laboratories for:

● Mycoplasma testing

● Viral assays

● Cell-based testing

● Molecular diagnostics

With deep expertise in method development, validation, and GLP/GMP-compliant testing, our team delivers fully customized virus testing solutions tailored to your project's needs.