Hycells Bio | Dedicated to Research on Cell and Animal Models for Drug Development
Release Date:
2022-12-21 11:34
Quality First, Innovation-Based
Quality First, Innovation Based
About Hycells
Shanghai Hycells Biotechnology Co., Ltd. has long been deeply engaged in the cell and gene therapy segment of large-molecule drug development. Since its inception, the company has leveraged a solid customer base and years of accumulated R&D service expertise to establish robust technological barriers, delivering highly satisfactory services that have earned a strong reputation among new-drug R&D companies. To date, it has forged long-term, stable partnerships with numerous leading CROs, cell therapy firms, and gene therapy enterprises. Moving forward, we will continue to optimize our clinical, technical, and business management systems as well as our service processes, thereby providing collaborative biopharmaceutical partners with services that meet even higher standards.
Technology Platform
Excellent Service Momentum
Service Catalog
Donor Library
Service Advantages
Quality Management System
1. Subject screening and enrollment, sample collection, and compliance in management
2. Complete ethical approval documentation that complies with the review requirements of the ethics committee and the company’s internal audit procedures, among other compliance obligations. We can provide on-site audit conditions to clients, thereby maximizing compliance and legality at every stage of the process.
3. Collaborate with multiple specialized cold-chain logistics providers to ensure end-to-end cold-chain transportation of individual blood samples, delivering them efficiently.
R&D Management System
1. Deeply cultivate the fields of cell therapy and gene therapy in the development of large-molecule drugs.
2. Continuously refine all preparation and R&D processes to elevate industry standards for manufacturing and service delivery.
3. Continuously explore and break new ground within the existing service process framework, expand the scope of services and research, and investigate additional service opportunities.
Professional Team
1. A dedicated R&D team with many years of experience in primary cell preparation has established a mature, standardized cell preparation process and manufacturing system.
2. A robust and stable database of healthy Chinese and foreign participants has been established, along with a participant management and project management system.
Resource Advantages
1. R&D space: 600 m² 2
2. World-class production and service equipment and laboratory environment
3. Establish multiple clinical collaboration centers, with the East China region serving as the lead hub, and forge long-term, stable partnerships with several Grade-III hospitals.
4. Our in-house specialized project team provides clients with services such as regulatory interpretation, policy analysis, domestic-investor identification, and approval from the National Health Commission, among others. In addition, we have extensive experience in obtaining approvals from the National Health Commission, and the partner hospitals involved demonstrate a high level of cooperation.
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
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