Pioneering a New Direction in Cell Therapy—The “Procedures for the Collection, Isolation, Culture, Preparation, and Quality Control of Human Peripheral Blood–Derived Natural Killer Cells,” co-authored by Hycells, Has Been Officially Released.
Release Date:
2026-05-25 17:05
Recently, the draft jointly prepared with the participation of Shanghai Hycells Biotechnology Co., Ltd. Procedures for the Collection, Isolation, Culture, Preparation, and Quality Control of Natural Killer Cells Derived from Human Peripheral Blood The group standard has been officially released. Its introduction marks a solid and pivotal step forward in the standardized and regulated development of natural killer (NK) cell therapy in China.
Industry pain points call for a “gold standard.”
In recent years, immune cell therapies—particularly those based on natural killer (NK) cells—have emerged as a major pillar of cancer immunotherapy. However, the absence of unified manufacturing and quality‑control standards has resulted in widely varying operational procedures and quality‑assurance metrics across institutions, undermining the comparability of treatment outcomes and severely hindering the broader adoption and dissemination of these approaches in clinical practice. Consequently, establishing a scientifically sound, rational, and practical set of standards for NK cell preparation has become an urgent priority for the field’s continued development.
An authoritative lineup elevates professional excellence.
This newly released “Procedures for the Collection, Isolation, Culture, Preparation, and Quality Control of Natural Killer Cells Derived from Human Peripheral Blood” (Standard No.: T/CI 1391—2025) , proposed by Qingdao Ruiside Biotechnology Co., Ltd., under the jurisdiction of the China International Science and Technology Promotion Association, and jointly compiled by dozens of national medical institutions and research institutes, including Xi’an Jiaotong University, Ocean University of China, Qilu Hospital of Shandong University, Qingdao University, and Shanghai Hycells Biotechnology Co., Ltd.
As a pioneer of innovation in the cell therapy field, Hycells Bio, leveraging its deep expertise in cellular immunotherapy, has been invited to serve as one of the drafting entities for this standard, working alongside numerous authoritative institutions to establish industry‑wide regulatory frameworks.
End-to-end coverage, establishing a comprehensive quality control closed loop.
This standard provides standardized operating procedures and quality‑control criteria for the isolation, culture, and preparation of NK cells from human peripheral blood, comprehensively covering all stages of NK cell production. Facilities, equipment, and personnel must comply with the… Good Manufacturing Practice for Pharmaceuticals 》(GMP) and relevant national standards.
1. Collection Standards: Clearly define the criteria for collecting peripheral blood samples and the requirements for donor screening. Donors must undergo health assessments—including testing for viral markers, blood pressure, and blood glucose—and sign an informed consent form. The collection environment must meet the standards of a Class III clean operating room, and all personnel involved in the collection must hold valid nursing licenses, thereby ensuring the safety and reliability of the materials at the source.
2. Separation and Purification: Standardize the process parameters for cell separation, employing Density gradient centrifugation Isolate PBMCs. Culture conditions: 37°C, 5% CO₂; avoid using human- or animal-derived serum; in the cryopreservation solution… Dimethyl sulfoxide The (DMSO) content does not exceed 10%.
3. Culture and Expansion: Standardize culture conditions and the operational environment to ensure cell viability and biological functionality.
4. Cell Cryopreservation and Preparation of Biological Products: The cryopreserved cell density is 5 × 10⁶ to 1 × 10⁸ cells per unit, and the cells are stored in liquid nitrogen at temperatures below −150°C. A unique identification and inventory traceability system has been established. Fresh or cryopreserved… PBMC All are suitable for the preparation of NK cell products.
5. Quality Control: A multidimensional quality-control system encompassing cell morphology, purity, viability, and microbial safety has been established, with stringent release‑testing and re‑testing criteria in place.
Cell characteristics: Viability of unfrozen cells ≥90%; viability after cryopreservation and thawing ≥70%; CD56⁺ ≥80%, CD45⁺ ≥90%, CD16⁺ ≥10%; normal karyotype (46 chromosomes, XX/XY).
Purity and Impurities: Detection of Exogenous Proteins and Antibiotic Residues.
Safety: Sterility, mycoplasma, endotoxin (≤0.5 EU/mL), and viruses (HIV, HBV, HCV, HTLV, EBV, CMV, TP) must all be negative.
Release Testing: Each batch must undergo rapid testing for viability, phenotype, microbiology, endotoxins, and other relevant parameters.
Re‑verification inspection: Conducted periodically by a reputable third-party organization.
6. Recording and Traceability: All records shall be retained for at least 30 years, and any amendments to records must bear a signature and date to ensure the traceability and confidentiality of documents.
In addition, Appendix A provides a detailed list of sample rejection criteria and corresponding corrective measures, covering situations such as non‑conforming labeling, inadequate transportation conditions, unsatisfactory donor health status, physical abnormalities in the samples, and contamination.
This end-to-end standardized management, spanning from “sample to finished product,” provides a robust foundation for ensuring the quality consistency, stability, and clinical safety of NK cell‑based therapeutic products.
Hycells Biology : Driving Innovation with Standards
From NK seed cells to HiXpan ® From in-depth technological development of its product portfolio to active participation in the formulation of industry standards, Hycells Bio has remained committed to advancing the standardized evolution of the cell‑therapy field. The release of this standard fills a critical gap in China’s quality‑control framework for the entire NK‑cell manufacturing process, providing a robust scientific foundation for the safety, consistency, and traceability of clinical‑grade NK‑cell products. As one of the drafting entities, Hycells Bio has not only demonstrated its technical expertise and industry influence in NK‑cell process development and quality control but has also made a pivotal transition from an innovator to a standards‑setter. By translating its proprietary experience into widely applicable industry standards, the company has made a significant contribution to elevating the overall quality of cell‑therapy products in China.
With the implementation of this standard, the cell therapy industry will usher in a more standardized and orderly development environment. Hycells Bio will continue to uphold the principle of “quality first, innovation as the foundation,” deepen its commitment to the cell therapy field, and consistently inject innovative momentum into the industry’s high-quality growth.
The full text of the group standard is available for download!
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