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Sample Service

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Sample Service

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Leukopak Collection Service

Leukopak is a concentrated blood fraction collected using a apheresis machine, primarily intended for the isolation of white blood cells (WBCs) from peripheral blood. WBCs are highly enriched in peripheral blood mononuclear cells (PBMCs), which consist mainly of T cells, B cells, NK cells, and monocytes. The WBC concentration in Leukopak is substantially higher—approximately 4–7 × 10^8 WBCs per milliliter—than that in whole blood, where the average is 5–7 × 10^6 WBCs per milliliter. In addition, the red blood cell (RBC) count in Leukopak is markedly reduced, with a ratio of about 2 RBCs to 1 WBC, whereas in whole blood the ratio is roughly 1,000 RBCs to 1 WBC. Moreover, the purity and quality of the WBC fraction in Leukopak are far superior to those in whole blood, typically containing more than 20-fold the amount of PBMCs. PBMCs are highly valued for their applications in immunotherapy research, cell therapy process development, and clinical settings. Consequently, WBCs have become the preferred starting material for cell therapy research and drug development.

PBMC Isolation Service

PBMC (peripheral blood mononuclear cell) refers to mononuclear cells in peripheral blood, including lymphocytes, monocytes, dendritic cells, and a small number of other cell types such as hematopoietic stem cells. Based on the source of the sample, PBMC can be classified as whole-blood–derived PBMC or apheresis–derived PBMC. Apheresis–derived PBMC is a component blood product obtained by leukapheresis using an apheresis machine; the majority of cells in this fraction are PBMC, with only a small proportion of granulocytes and erythrocytes.

CD3+ Cell Sorting Service

CD3 is an important leukocyte differentiation antigen that is expressed on the surface of nearly all T cells. It consists of four genetic loci and six polypeptide chains, and serves as a membrane-associated antigen that forms part of the T-cell antigen receptor (TCR). Upon antigen–TCR engagement, CD3 mediates intracellular signal transduction, regulates T-cell differentiation—including the lineage commitment and activation of helper T cells and cytotoxic T cells—facilitates cytokine secretion and apoptosis, and influences ligand-receptor interactions, thereby playing a critical role in the diverse functional activities of T cells.

CD4+ Cell Sorting Service

CD4 cells refer to T lymphocytes that express the CD4 molecule on their surface; they are a crucial type of immune cell in the human body. Because HIV primarily targets CD4+ T cells, the results of CD4 cell count testing play an important role in assessing the efficacy of AIDS treatment and evaluating the patient’s immune function.

CD4+ Naive T Cell Sorting Service

Among helper T cells, naïve CD4+ T cells that have not yet been stimulated by antigens are designated as Th0. Upon maturation and activation, these cells can execute a variety of antigen-dependent effector functions. Based on their distinct functional profiles, CD4+ T cells can be classified into several Th cell subsets, including Th1, Th2, Th3, Treg, Tr1, Tfh, Th17, Th9, and Th22. These Th subsets engage in intricate interplay and coordinate their activities to exert immunoregulatory effects, thereby maintaining homeostasis of the organism.

CD8+ cytotoxic T cells

CD8+ cytotoxic T cells are considered the primary effector cells of anti-tumor immunity. Their restricted and antigen-specific recognition of tumor-associated antigens (TA) via class I MHC molecules, combined with their ability to produce perforin and other cytotoxins upon activation, enables them to induce tumor cell death while sparing normal cells.

Leukopak Collection Service

Compliance Approval

Recruitment and Screening

Collect

Quality Control

Sample Delivery

Compliance Approval

In strict accordance with regulatory requirements set forth in the Regulations on the Administration of Human Genetic Resources, the Good Clinical Practice for Drug Clinical Trials, and other relevant laws and regulations, we conduct compliant project applications and approvals to comprehensively ensure that our services are lawful and compliant.

Recruitment and Screening

We have established stable partnerships with multiple recruitment agencies and a robust re-recruitment mechanism, rigorously screening donors based on nationality, occupation, health status, and other criteria to ensure sample quality from the very source.

Collect

Establish long-term, stable partnerships with fully accredited and well-managed hospitals, equipped with dedicated personnel and specialized equipment to ensure the safety and stability of the entire blood-collection process.

Quality Control

Establish a comprehensive quality control system that ensures end-to-end recording and full traceability of all quality-control data, thereby guaranteeing the stability and reliability of service delivery.

Sample Delivery

Entrust a professionally qualified cold-chain logistics company to ensure the rapid and secure delivery of samples.

Leukopak is a concentrated blood component fraction collected using a apheresis machine, primarily intended for the isolation of white blood cells (WBCs) from peripheral blood. White blood cells are rich in peripheral blood mononuclear cells (PBMCs), which consist mainly of T cells, B cells, NK cells, and monocytes. cellular composition. The leukocyte concentration in leukopak is substantially higher—approximately 4–7 × 10^8 leukocytes per milliliter—than that in whole blood, which averages 5–7 × 10^6 leukocytes per milliliter. Moreover, the red blood cell (RBC) to leukocyte ratio is markedly reduced, at about 2 RBCs per 1 WBC, whereas in whole blood the ratio is roughly 1 WBC per 1,000 RBCs. In addition, the purity and quality of the leukocyte fraction are far superior to those of whole blood, typically containing more than 20-fold the mononuclear cell content. PBMCs are highly valued for their applications in immunotherapy research, cell therapy process development, and clinical settings. Consequently, leukocytes have become the preferred starting material for cell therapy research and drug development.

Background Information—Compliance

First: Clinical trials of drugs shall adhere to two fundamental principles—scientific rigor and ethical appropriateness. Ethical review by an institutional review board is a critical measure for safeguarding the safety and rights of trial participants and ensuring the ethical soundness of clinical trials, playing a vital role in drug clinical research.

Second: In accordance with relevant regulations, clinical trials involving drugs must be submitted to the appropriate ethics committee for review. In 2003, the National Medical Products Administration issued the Good Clinical Practice for Drug Clinical Trials (GCP), which confers upon ethics committees the critical function of conducting ethical review and granting approval for applications to conduct drug clinical trials.

3. Our company places great emphasis on the compliance of human-sourced sample use and provides supporting services, including obtaining independent ethics approval on behalf of our partners. This helps mitigate communication challenges between partners and ethics committees and ensures the smooth execution of projects.

4. Obtain informed consent from each participant to ensure that everyone fully understands the risks and benefits associated with the study.

5. All experiments involving human-derived samples are conducted in a BSL-2 laboratory.

Complete process:

Service Description:

1. Project Initiation: Following the client’s approval to proceed with the project, our dedicated PM team will undertake pre-launch project training, conduct and evaluate feasibility studies for the research center, submit ethical review documentation to the ethics committee, draft and submit the research center contract, and provide ongoing project oversight until the ethics approval is obtained.

2. Project Execution: Upon receipt of ethical approval, our company’s dedicated CRC team will assume responsibility for project execution, including site documentation and data management, as well as regular progress reporting.

3. Subject Management: explanation and signing of the informed consent form, comprehensive medical screening, and follow-up recruitment of subjects, among other tasks.

3. Sample Transportation: Professional cold-chain logistics providers ensure that samples are transported at the appropriate temperature and within the required time frame.

4. Sample Testing: Samples can be retained for testing, including bacterial, fungal, and mycoplasma analyses, as well as flow cytometry.

Delivery Standards:

Sample Delivery Specification (million/instance)	Sample Delivery Format
10 / 25 / 50 / 100	Cryopreservation
25 / 50 / 75 / 100 / 150 / 200 / 300 / 500 / 1000	Fresh

Release Criteria:

Cell count	Cell viability	CD34+ proportion	Bacterial and Fungal Detection (PCR)	Mycoplasma Detection (PCR)	HAV, HBV, HCV, HIV, TPAb, HTLV, EB, B19
> Specification Quantity	>90%	>90%	Negative	Negative	Negative

Service Advantages ：

Quality System

1. Strictly adhere to the protocols for subject screening, sample collection, and sample management.

2. Complete ethical approval documentation that complies with the review requirements of the ethics committee and other regulatory compliance obligations, including corporate audits. Supports on-site client inspections.

3. A professional cold-chain logistics collaboration system ensures compliant and efficient delivery of samples throughout the entire process.

R&D System

1. Focused on cell therapy, gene therapy, and the development of large-molecule drugs.

2. Continuously optimize standardized preparation processes and lead industry service standards.

3. Innovate service models and expand the boundaries of research applications

Professional Team

1. A seasoned R&D team and a mature, standardized cell preparation process and manufacturing system.

2. Standardized donor registry and management system covering both Chinese and international populations

Core Resources

1. World-class production and service equipment, state-of-the-art laboratory facilities, and a nearly 1,000-square-meter R&D center.

2. Establish multiple clinical collaboration centers, with the East China region as the leading hub, covering tertiary hospitals nationwide and high-quality GCP management centers.

3. Our in-house specialized project team can provide clients with services such as regulatory interpretation, policy analysis, domestic-investor qualification determination, and approval for foreign-invested cooperation, offering one-stop compliance support.

Sample COA: