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
Related News
HiXpan® Cell Culture Additive: Answers to Key Questions (Part 2)
Hycell’s maximum production capacity per batch is 200–400 units of the 500 mL format, ensuring stable supply and meeting customers’ ongoing production needs.
HiXpan® Cell Culture Additive: Key Questions and Answers (Part 1)
The blood‑derived raw materials used in HiXpan® cell culture additives comply with all regulatory requirements throughout collection, ethical review, informed consent, and commercial authorization, and are supported by a fully traceable supply chain.
This paper focuses on how Hycells transforms biological variability into engineering‑level determinism through a scientifically informed blending strategy and stringent control at the collection end.
(II) Security Assurance Section | Safety First, Defense Prioritized
Compliance‑driven traceability establishes a clear “identity” for the product, but the real test lies in safety. While a multi‑donor pooling strategy ensures batch‑to‑batch consistency, it also inevitably elevates the risk of pathogen introduction. In the face of these associated risks and challenges, Heyousheng has never compromised on its manufacturing standards—relying on more precise design to deliver on its promise of enhanced safety.
This article will examine how Hycells proactively integrates the quality management system into the hospital setting, translating compliance requirements into concrete, actionable practices starting at the sample collection stage, thereby establishing a trust‑based chain that can withstand audit scrutiny.
In selecting hPL raw materials, Heyousheng consistently upholds the principle that “safety is determined at the source.” The samples used in production are rigorously collected in accordance with applicable standards and undergo stringent donor screening, effectively mitigating the risk of disease transmission at the very outset. Moreover, from informed consent forms and ethical approvals to clinical‑grade collection under the GCP framework, Heyousheng has established a fully traceable documentation chain, ensuring that every sample is accounted for and verifiable. In contrast to the industry’s longstanding reliance on the conventional model of using expired blood supplies from blood banks, this approach represents a structural, generational upgrade.
Contact Us
Phone: 021-36696819
Mobile phone:13061948224(Ms. Yu)
Email:monika@hys-bio.com
Wuxi Headquarters: 4th Floor, No. 15-1, Xianfeng Middle Road, Anzhen Subdistrict, Xishan District, Wuxi City
Shanghai Branch: Room 503, Building 2, No. 999 Jiangyue Road, Minhang District, Shanghai
Official Website
WeChat Official Account
Message Board