HiXpan® MSC Serum-Free Expansion Kit | GMP‑grade, ready for drug registration
Release Date:
2026-07-22 14:14
With the issuance of National Document No. 818 ( Regulations on the Clinical Research and Clinical Translation of New Biomedical Technologies ) Officially implemented on May 1, 2026, the stem cell field has officially entered a new era of “safety and compliance, scientific innovation.” Mesenchymal stem cells (MSCs) are transitioning from the laboratory to clinical practice, with the safety and stability of culture systems remaining the cornerstone of translational research. How can we achieve efficient, stable expansion of MSCs derived from different tissue sources within a compliant regulatory framework? Hycells, backed by data, has launched HiXpan, which encompasses compliant seed cells and meets GMP‑compliant manufacturing standards. ® A one-stop solution for serum-free culture kits, redefining industry standards.
Core product: HiXpan ® MSC Serum-Free Expansion Kit
Specifically designed for MSCs derived from multiple tissue sources, it offers the following key advantages:
Broad-spectrum applicability : Perfectly compatible with a variety of human-derived mesenchymal stem cells, including umbilical cord, bone marrow, and adipose tissue, supporting primary cell isolation via outgrowth and scalable, stable expansion.
Efficient amplification : Exhibits a faster proliferation rate, maintains stable passage for more than 15 passages, and remarkably preserves cellular differentiation potential.
Ready-to-use design : No coating required, no additional reagents needed, significantly simplifying the workflow.
GMP grade, free of heterologous ingredients : Completely eliminate the risk of animal-derived contamination and meet clinical cell‑manufacturing compliance requirements.
Core Application Scenario Data Display:
Hycells conducted data validation on MSCs derived from umbilical cord, adipose tissue, and bone marrow.
Scenario 1: Expansion of MSCs Derived from the Umbilical Cord
Experiments demonstrate that the HeYou MSC amplification kits from two different batches both exhibit significantly superior overall culture performance compared to well-known mainstream brands on the market.
Batch-to-batch stability: Two batches of the MSC serum-free expansion kit demonstrated high consistency, demonstrating that MSC333 can reliably deliver its performance potential and ensuring the reliability and reproducibility of each expansion run.
Competitive Advantage: In the critical application of umbilical cord MSCs, the Hycells serum-free expansion kit for MSCs demonstrates a clear competitive edge.
Scenario 2: Bone marrow–derived MSCs
The experiments encompassed two critical stages of bone marrow–derived MSCs: ① primary culture and cell adhesion; and ② passaging and expansion. The MSC333 system performed well in both respects. As bone marrow is a classic source of MSCs, these results provide strong validation for the reliable application of MSC333 in conventional tissue‑derived cell cultures.
Scenario 3: Adipose-derived MSCs
Day 7 climbing assays revealed that the MSC333 group exhibited superior climbing efficiency and cell morphology, further confirming the product’s broad applicability in adipose‑derived MSCs.
GMP Production Quality Implementation
Hycells has successfully achieved commercial-scale implementation under a stringent GMP quality system:
Production facilities: The Wuxi Center focuses on R&D, manufacturing, and commercialization, with a total area exceeding 3,000 square meters.
Quality Certification: It has obtained certification under the GB/T 19001-2016/ISO 9001:2015 quality management system.
Production Capacity and Compliance: We provide a complete, transparent, and auditable compliance documentation chain—from production records to full‑scale quality inspection reports—fully supporting IND submissions.
Broad-spectrum, highly effective, safe, and compliant—setting a new industry benchmark.
Hycells HiXpan ® The MSC serum-free expansion kit, backed by authentic and reliable experimental data and leveraging Hycells’s compliant MSC seed cells, delivers a comprehensive, one-stop solution for MSC culture, facilitating seamless integration between research and production.
Broad-spectrum: Fully supports MSCs derived from multiple tissue sources, including umbilical cord, bone marrow, and adipose tissue.
Efficient: It outperforms mainstream market brands in both primary and passaged cultures, with minimal batch-to-batch variability and consistently stable performance.
Safety: Serum-free, xenogeneic‑free, with stringent GMP quality control and full donor traceability.
Compliance: Compliant with IND submission and IIT research Requirement: Provide a complete and compliant documentation chain.
Domestically produced culture media have already demonstrated strong performance in cell proliferation and subculture stability. As a pioneer and driving force in this field, Hycells Bio is committed to delivering a stable, compliant, and exceptionally reliable one-stop culture‑media solution that exceeds the expectations of researchers and clinicians alike.
Scan the code for a chance to try HiXpan for free. ® The MSC serum-free expansion kit delivers an immediate, high‑efficiency culture experience. For more details about the Hycells MSC serum-free expansion kit, please contact our sales representative.
Contact: Ms. Yu, 13061948224.
Related News
(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 He Yousheng 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.
Recently, the research team led by Researcher Bian Yingjie at the Guangzhou National Laboratory, in collaboration with partners from Sun Yat-sen University, published a study titled “Iron overload in the tumor microenvironment induces CD8⁺ T cell ferroptosis and dysfunction” in the internationally renowned academic journal Nature Communications.
Hycells Recruitment | Never Stop Exploring, Never Stop Innovating
The company consistently upholds its core values of “people‑centricity, quality first, and innovation as the foundation,” remains driven by technological innovation, and sets new industry benchmarks for domestic innovation, thereby laying a solid foundation for the development and global advancement of China’s innovative pharmaceutical sector.
The HiXpan® NK Serum-Free Culture Kit, Version 3.0, is manufactured in strict compliance with GMP standards, and its production system fully adheres to relevant guidelines and regulations, including the “818 Requirements,” positioning it for pharmaceutical‑grade manufacturing and applications.
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