Good News | We are delighted to announce that Hycells has officially become a service agent for Suzhou Yudeyang Biotechnology Co., Ltd.!
Release Date:
2023-03-14 13:07
Part 01
Hycells has officially become the agent for Yude Yang.
Suzhou Yudeyang Biotechnology Co., Ltd. was established in January 2020 and is dedicated to biopharmaceutical-related Organism Security Testing Services of the company. At present, a comprehensive MCB/WCB/EOPC/UPB A cell bank testing and viral clearance validation platform, equipped with GMP and GLP quality systems that comply with both Chinese and U.S. regulatory requirements. Possessing Successful China-U.S. Application Cases Experience ， Fully capable of meeting biopharmaceutical clients’ regulatory submission requirements for IND/BLA applications. In China, in addition to Suzhou WuXi Testing, which offers comprehensive biosafety testing that meets both Chinese and U.S. regulatory submission requirements, Yudeyang is the second testing platform capable of fulfilling these regulatory requirements.
On March 14, 2023, Mr. Zhou Bin, General Manager of Shanghai Hycells Biotechnology Co., Ltd., formally signed an agency agreement with Dr. Li Yuxiu, CEO of Suzhou Yudeyang Biotechnology Co., Ltd.!
At this signing ceremony, Hycells was granted exclusive agency rights for the Suzhou Yudeyang Testing Services project in China, marking another significant step in Hycells’s strategic expansion. Moving forward, the two parties will work together to develop new markets. We warmly welcome both new and existing clients to contact us for more information on these services.
Hotline: 021-36696819
Mobile phone: Mr. Xie, 15236077080
Email: info@hys-bio.com
Official website: www.hys-bio.com
Address: Room 503, Building 2, No. 999 Jiangyue Road, Minhang District, Shanghai
The photo shows the scene at the Yudeyang Laboratory.
Part 02
Testing Platform and Technical Advantages
Platform Advantages
1. Quality Assurance
The quality management system complies with CMA, ISO, GLP, and GMP quality standards and holds ISO 9001, CMA, and BSL-2 laboratory accreditation.
2. Audit Declaration
Conducting FDA, EMA, and PMDA audits as well as client audits, and providing support for IND/BLA submissions, with proven success in both U.S. and Chinese regulatory filings.
3. Strict Management
All documents, including analytical method validation reports, study protocols, raw data, and test reports, have been reviewed and verified, and all critical steps and operational procedures have undergone internal verification.
4. Customer First
Our GMP testing and release services are conducted following a client-initiated on-site audit to ensure compliance with the client’s GMP requirements, after which testing is performed in accordance with the client’s specifications.
Technical Advantages
1. Thirteen viral libraries have been established, including those for xMuLV, PrV, Reo3, MMV, MEV, EMCV, HHV-1, PI-3, Ad5, SV-40, BVDV, BAV, and BRSV.
2. Master various serum-free or low-serum production processes for viruses, with a viral stock titer of 10 6 ~10 8 between TCID50/mL.
3. Downstream processes such as TFF, SEC, and AEX are employed for virus concentration and purification, enabling the viral titer to reach 10 after concentration. 8 ~10 9 between TCID50/mL
4. High-purity viruses shall be used for virus clearance validation to prevent impurities from interfering with the process, reducing the industrial flow rate, and compromising the validity of the validation results.
5. High viral load allows for a wide verification range.
Part 03
Test Details
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Contact Us
Phone: 021-36696819
Mobile phone:13061948224(Ms. Yu)
Email:monika@hys-bio.com
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