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Sample Service

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Sample Service

Recommended Information

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.

NTreg Natural Regulatory T Cell Sorting Service

Regulatory T cells (Tregs) are a subset of T cells that modulate autoimmune reactivity within the body and play a crucial role in maintaining immune tolerance. They are generated in the thymus, then exported to the peripheral tissues, where they actively suppress the activation and proliferation of potentially autoreactive T cells present in healthy individuals, thereby regulating immune responses and preventing the development of autoimmune diseases.

Compliance Approval

Recruitment and Screening

Collect

Separation and preparation

Cell sorting

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 outset.

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.

Separation and preparation

Establish a stringent cell isolation and preparation system, employing standardized procedures to ensure the acquisition of high-purity, high-quality target cells.

Cell sorting

Magnetic bead-based sorting technology is employed to precisely isolate PBMC subpopulations, meeting the diverse needs of research and clinical applications.

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.

I. Sample Introduction:

Regulatory T cells can be classified into naturally occurring natural regulatory T cells (nTregs) and inducibly generated adaptive regulatory T cells (aTregs or iTregs). Natural regulatory T cells (nTregs) are predominantly CD4+CD25+ Tregs, accounting for approximately 5% to 10% of CD4+ T cells in peripheral blood and the spleen. In addition to expressing CD4 and CD25 molecules, a hallmark of CD4+CD25+ Tregs is their high-level expression of the transcription factor Foxp3. Foxp3 not only serves as a marker molecule for CD4+CD25+ Tregs but also functions as a critical gene that determines their immunoregulatory function. A reduction in the number of CD4+CD25+/Foxp3+ cells or dysfunction of these cells can lead to the development of autoimmune diseases. Moreover, regulatory T cells can suppress anti-tumor immune responses, thereby increasing mortality; they are also utilized for monitoring patients before and after bone marrow transplantation.

Delivery method:

Delivery Specification (million/instance)	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. Strict adherence to subject screening ， Standards for Sample Collection and Management

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

3. Professional Cold-Chain Logistics Cooperation system , ensuring the entire sample process Compliant and Efficient Delivery

R&D System

1. Focus in Cell therapy and Gene therapy and large-molecule drug development

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. Standardization covering both Chinese and international populations Donor Registry and management system

Core Resources

1. World-class production and service equipment, as well as laboratory facilities, nearly 1,000-square-meter R&D base

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. ， Providing one-stop compliance support

II. Sample COA: