Humanized immune system mouse models—by rebuilding human immunity in immunodeficient mice—have become the critical bridge between in vitro research and clinical trials. Alfa Cytology's Hu-Immune™ platform, built on globally leading and extensively validated model strains, delivers a highly standardized, data-reliable solution. Beyond offering multiple model types, we provide end-to-end in-vivo preclinical efficacy studies on these models to accelerate drug development in immuno-oncology and inflammatory diseases.
Humanized immune system (HIS) mouse models introduce human immune cells or hematopoietic systems into mice, creating an in vivo milieu closer to clinical reality. The rapid rise of immunotherapies (checkpoint inhibitors, T-cell engagers/bsAbs, CAR‑T/NK, etc.) has positioned HIS as a go‑to platform for mechanism validation, dose exploration, and combination strategy assessment. Typical readouts include TGI, OS, IVIS, IHC/IF, flow immunophenotyping, and cytokine panels; multi‑omics can be added to strengthen the evidence chain. Importantly, HIS is not a "mini clinical trial." Peripheral and intratumoral contexts remain constrained by the host background. Robust study design (time window, visit schedule, sample size/power) and tight QC are essential for interpretable, translatable results.
Fig. 1 Humanized mouse models. (Allen, T. M., et al., 2019)
Humanized immune system mouse models are powerful tools in biomedical research. These models are developed through various approaches to recapitulate key aspects of the human immune system in mice. Below are some common types of these models:
| Type | Features | Applications | Note |
|---|---|---|---|
| huPBMC (human PBMC-engrafted) | Fast setup; T cell–dominant reconstitution; strong immune activation; clear readouts within a limited observation window. | Cell therapy functional validation (e.g., CAR-T/NK activity & persistence screening); Checkpoint inhibitor efficacy (PD-1/PD-L1, CTLA-4); GVHD models & immune-related toxicity observation. | Choose when you need speed and robust immune responses. |
| huHSC (human CD34⁺ HSC–engrafted) | Multi-lineage, systemic, long-term reconstitution; closer to a complete human immune ecosystem. | Immune system development & maturation; long-acting immunotherapy evaluation, combo strategies & resistance mechanisms; autoimmune/inflammation modeling & biomarker work. | Choose for stability, multi-lineage breadth, and mechanistic depth over longer timelines. |
Hu-Immune™ is Alfa Cytology's humanized immune system research engine for immunotherapy R&D. We reconstruct the human immune system in immunodeficient mice and provide an integrated offering that spans model supply and in vivo preclinical efficacy assessment. Built on an industry-validated model foundation, the platform pairs standardized experimental systems with customizable study designs to generate clinically relevant, reproducible, and filing-ready evidence across immuno-oncology and inflammation/autoimmunity. We offer two model routes—huPBMC humanized model and huHSC humanized model—to meet both rapid, strong immune readouts and multi-lineage, long-term, system-level research needs. The end-to-end workflow covers model construction/supply, study design, dosing & monitoring, multi-omics and pathology, statistical analysis & reporting, and includes one-on-one collaboration with senior scientists to co-create experimental designs and translate in vivo readouts into actionable R&D decisions.
The following table compares key features of leading HIS mouse model platforms in the industry. This comparison highlights how Alfa Cytology's Hu-Immune™ platform distinguishes itself through its focus on precision subtype models and integrated, end-to-end service delivery.
| Company Name | HIS Platforms | Features |
|---|---|---|
| Competitor 1 | Platform 1 | Offering standardized huPBMC and huHSC models on the classic NOG immunodeficient background, emphasizing validated protocols and rigorous QC. |
| Competitor 2 | Platform 2 | Providing an integrated kit solution (NCG mice with pre-screened PBMCs) designed for operational convenience and high experimental consistency. |
| Competitor 3 | Platform 3 | Providing platform-based huPBMC and huHSC models on immunodeficient mice (like NCG), focusing on rapid and reliable humanized system reconstruction for oncology and immuno-oncology research. |
| Alfa Cytology- Hu-Immune™ | Hu-Immune™ | The Hu-Immune™ Platform delivers precision subtype models targeting specific immune cell functions, combined with rigorous QC protocols that ensure high engraftment levels and exceptional lot-to-lot consistency. Our integrated workflow provides end-to-end services from model generation to in vivo efficacy studies, supported by dedicated scientific partnership throughout model selection and data interpretation. |
Project Definition & Host Selection
Human Donor Material & Cell Preparation
Recipient Conditioning
Engraftment / Transplantation
Reconstitution & Quality Control (QC)
Humanized immune system mouse models are a powerful bridge between in vitro discovery and clinical translation in immuno-oncology and inflammation. Alfa Cytology's Hu-Immune™ platform combines industry-validated host backgrounds with standardized yet configurable workflows to deliver reproducible, clinically relevant in vivo readouts. We support both huPBMC and huHSC, alongside end-to-end services.
A rapid humanization approach based on PBMCs with T cell–dominant reconstitution, delivering strong immune readouts within a limited study window—ideal for candidate screening and in vivo mechanism verification. Supported subtypes: huPBMC-T, huPBMC-NK/B, huPBMC-Mono, huPBMC-MHC KO, respectively emphasizing T-cell, NK/B-cell, myeloid readouts, and extended study windows.
A multi-lineage, long-term humanization approach using human CD34⁺ hematopoietic stem cells, reconstructing T/B/NK/myeloid compartments for mid- to long-term efficacy studies, combination strategies, and biomarker discovery—offering greater system-level fidelity and translational relevance.
Overview
Evaluate antitumor activity of a CD3 bispecific antibody (BsAb) and confirm robust human immune reconstitution in Hu-Immune™ huPBMC humanized NCG model.
Study Information
Results
Fig.2 CD3 BsAb efficacy study in huPBMC Humanized Model.
Overview
Assess antitumor activity and immune reconstitution in huPBMC-T humanized NCG model using a Treg-modulating anti-CD25 antibody and a cytokine regimen.
Study Information
Results
Fig. 3 Antitumor efficacy and human immune reconstitution in huPBMC-T humanized NCG model.
Leverage Alfa Cytology's Hu-Immune™ platform—featuring validated huPBMC and huHSC humanized immune system models—to accelerate preclinical in vivo discovery with confidence. From model supply and study design to dosing & monitoring, multi-omics/pathology, and statistical reporting, our expert team delivers standardized yet configurable workflows for reproducible, clinically relevant readouts. Whether you're advancing mechanism validation, prioritizing candidates, or building biomarker evidence, we're here to help you move faster—and smarter. Contact Us today to explore collaboration opportunities and request a custom proposal.
Reference
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Alfa Cytology is a leading preclinical research partner specializing in humanized immune system mouse models for immuno-oncology and inflammation research.
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