Hematology models and translational technologies in non-human primates

Prisys Biotech provides non-human primate (NHP) models and supporting technologies for hematology, hemostasis, thrombosis, anemia, and emergency medicine research. The portfolio includes bleeding models, hemophilia A, arteriovenous (A-V) shunt thrombosis, endotoxemia, arterial thrombosis, venous thrombosis, anemia, and acute blood loss or hemorrhagic shock.

These models can be combined with clinical pathology, coagulation testing, thromboelastography, DSA-guided procedures, real-time blood-flow monitoring, imaging, biosampling, pharmacology, and PK/PD assessments. The model and endpoint package are selected according to the therapeutic mechanism, target, modality, and development question.

Hematology models at a glance

Prisys Biotech's NHP hematology platform covers primary and secondary hemostasis, coagulation, platelet-related thrombosis, blood-loss conditions, anemia, vascular occlusion, and systemic inflammatory responses. The following models are available for protocol discussion, subject to scientific fit, model availability, and study-specific design.

Bleeding models

Prisys Biotech supports several controlled bleeding procedures for evaluating hemostatic agents, anticoagulants, antihemophilic therapies, and other interventions that affect blood loss or bleeding duration.

The reference material includes the following bleeding model formats:

  • forearm vein bleeding, including studies with low-molecular-weight heparin (LMWH);
  • tail-vein bleeding, including studies with warfarin or other anticoagulant conditions;
  • oral mucosal bleeding using a standardized mucosal incision and measurement of bleeding time and blood loss;
  • Surgicutt skin bleeding for skin bleeding-time assessment;
  • tail-tip bleeding;
  • fingertip bleeding; and
  • arterial bleeding procedures that may be used for anemia induction or blood-loss studies.

Depending on the procedure, endpoints may include bleeding time, blood loss, hemoglobin, hematocrit, serial blood counts, coagulation parameters, and treatment-related changes. The choice of bleeding site and procedure should match the pharmacological question and the required sensitivity to the test article.

Forearm and tail-vein bleeding

Forearm and tail-vein procedures provide venous bleeding endpoints that can be used to evaluate changes in bleeding time and, where applicable, blood loss. They may be used repeatedly or in combination with anticoagulant conditions when the protocol and animal-welfare requirements support that design.

Oral mucosal bleeding

The oral mucosal bleeding procedure uses a controlled mucosal incision in a sedated cynomolgus monkey. Bleeding time and blood loss can be measured as endpoints for hemostatic or antithrombotic drug studies.

Surgicutt, tail-tip, and fingertip bleeding

Surgicutt, tail-tip, and fingertip procedures provide small-volume bleeding or bleeding-time endpoints. The reference comparison indicates that these procedures differ in tissue type, average bleeding time, blood loss, and suitability for repeated testing. The final procedure should be selected according to the drug mechanism and study objectives.

Hemophilia A model

The NHP hemophilia A model supports the evaluation of therapies for factor VIII deficiency or factor VIII inhibition, including replacement products, bypassing agents, and other hemostatic approaches.

The reference material describes an inhibitor-mediated severe bleeding model using an intravenous bolus of a sheep anti-human factor VIII polyclonal antibody. APTT is monitored after administration, and tail-vein bleeding is assessed during the defined observation period. Blood samples can be collected for APTT analysis and other protocol-defined hematology or coagulation endpoints.

Potential study endpoints include:

  • APTT and other coagulation parameters;
  • bleeding time and blood loss;
  • residual hemoglobin or hemoglobin change after a defined bleeding challenge;
  • pharmacokinetics and pharmacodynamics of the test article; and
  • acute or prophylactic efficacy against bleeding.

The inhibitor type, dose, timing, bleeding challenge, number of bleeding sessions, and endpoint schedule should be confirmed during protocol development.

Arteriovenous shunt thrombosis model

The NHP A-V shunt model is used to study thrombus formation under blood-flow conditions and to evaluate antithrombotic or anticoagulant therapies. A specialized arteriovenous shunt is placed between the arterial and venous circulation, with clot formation materials incorporated into the shunt circuit.

The model can engage both primary and secondary hemostasis, including platelet aggregation and coagulation-cascade activity. Potential endpoints include:

  • thrombus wet weight;
  • APTT and PT;
  • clot formation or suppression within the shunt;
  • treatment-related changes in thrombus burden; and
  • other protocol-defined coagulation or pharmacodynamic measurements.

The reference material includes an A-V shunt study with dabigatran. The test article, dose, shunt configuration, observation period, and analysis plan should be adapted to the development program.

Endotoxemia model

The NHP endotoxemia model supports research into acute systemic inflammatory responses, coagulation changes, vascular effects, and candidate therapies for endotoxin-associated conditions. It can be used to examine the interaction between inflammation and hemostasis under a controlled experimental design.

Depending on the protocol, endpoints may include clinical observations, temperature and cardiovascular parameters, CBC, coagulation tests, fibrinogen, D-dimer, cytokines, blood chemistry, and other pharmacodynamic biomarkers. The endotoxin source, dose, route, monitoring schedule, and stopping criteria require protocol-specific confirmation.

Arterial thrombosis model

Prisys Biotech supports exploratory NHP arterial thrombosis workflows for antithrombotic and thrombolytic efficacy evaluation. The reference material describes a Hybrid Folts model that combines DSA-guided vascular injury with constrictor-induced stenosis and real-time flow monitoring.

The procedure may include:

  1. DSA-guided placement of a balloon catheter;
  2. balloon inflation to produce controlled endothelial injury;
  3. placement of a vascular constrictor to produce stenosis;
  4. continuous monitoring with a Transonic perivascular flowmeter; and
  5. analysis of cyclic flow reduction (CFR), flow velocity, and time to occlusion.

Potential endpoints include DSA findings, Vmax, Vmin, Vmean, CFR frequency or pattern, time to occlusion, thrombus formation, and treatment-related restoration of flow. The model status, reproducibility criteria, and internal performance data should be confirmed before publication as external website claims.

Venous thrombosis model

The exploratory NHP venous thrombosis workflow uses a venous ligation procedure to evaluate thrombus formation and the effects of anticoagulants or other biologics. The reference material describes jugular-vein ligation and monitoring for venous thrombosis after the procedure.

Potential endpoints include:

  • thrombus formation or absence of thrombus;
  • time to thrombus formation;
  • thrombus-related imaging or pathology findings;
  • coagulation parameters; and
  • comparative efficacy or safety of anticoagulant candidates.

The ligation method, observation window, endpoint definition, and histological assessment plan should be specified in the study protocol.

Anemia model

The phlebotomy-induced anemia model is used to study reduced circulating blood volume, hematological recovery, and treatment response. It can support evaluation of therapies intended to improve anemia, stimulate erythropoiesis, manage blood loss, or restore hematological parameters.

The reference material includes repeated blood collection with monitoring of hematology parameters. Potential endpoints may include CBC, hemoglobin, hematocrit, red blood cell indices, reticulocytes, blood chemistry, and recovery over time. Additional measurements such as HbF, HbA, or other red-cell-related parameters can be included when relevant to the therapeutic mechanism.

The blood-volume reduction, sampling schedule, severity criteria, supportive care, and recovery period must be defined in the protocol.

Acute blood loss and hemorrhagic shock model

The phlebotomy-induced NHP hemorrhagic shock model supports research into acute blood loss, circulatory compromise, resuscitation, hemostatic intervention, and emergency-care therapies.

The reference material describes catheterization of the femoral artery and vein for controlled exsanguination and physiological monitoring. Possible monitoring parameters include arterial pressure, blood gas analysis, CBC, coagulation tests, heart rate, lactate, base excess, and mean arterial pressure.

Potential endpoints may include:

  • change in blood pressure and cardiovascular status;
  • blood gas, lactate, and acid-base changes;
  • CBC and coagulation response;
  • time to reach protocol-defined shock criteria;
  • survival or recovery-related endpoints, where scientifically and ethically justified; and
  • efficacy of fluids, blood products, hemostatic agents, vasopressors, or other interventions.

The blood-loss rate, total blood-volume reduction, shock definition, resuscitation plan, monitoring schedule, and humane endpoints must be agreed during protocol development.

Technologies supporting NHP hematology studies

Prisys Biotech combines NHP hematology models with clinical pathology, coagulation analysis, imaging, flow monitoring, biosampling, and pharmacology. A project may use one technology or several methods, depending on the research question.

Clinical pathology and hematology testing

The hematology research platform includes clinical pathology capabilities such as:

  • complete blood count (CBC);
  • blood chemistry;
  • APTT;
  • PT;
  • TT;
  • fibrinogen;
  • D-dimer; and
  • other protocol-defined hematology or coagulation tests.

These measurements can be used to characterize baseline status, confirm model induction, follow treatment response, and connect systemic exposure with hematological or coagulation effects.

Thromboelastography

Thromboelastography (TEG) provides a whole-blood view of clot formation, clot strength, and clot breakdown. It can complement standard plasma coagulation tests when the study requires a broader assessment of hemostatic function.

TEG parameters and sampling times should be selected according to the intervention, model, and intended pharmacodynamic interpretation.

Magnetic Resonance Imaging (MRI)
MRI and advanced imaging sequences

DSA-guided vascular procedures

Digital subtraction angiography (DSA) can support vascular visualization, catheter placement, model induction, and confirmation of vascular changes. In arterial thrombosis studies, DSA can be combined with balloon-mediated endothelial injury, vascular constriction, and real-time flow monitoring.

DSA-Guided Interventional Platform For NHP Research | Prisys Biotech

The imaging schedule, contrast-agent use, target vessel, and procedure should be specified in the protocol.

Real-time blood-flow monitoring

A Transonic perivascular flowmeter can provide quantitative blood-flow measurements during selected vascular thrombosis procedures. Potential readouts include maximum, minimum, and mean flow velocity, cyclic flow reduction, and time to occlusion.

These readouts may be used alongside DSA, thrombus assessment, coagulation tests, and pharmacodynamic measurements to evaluate treatment effects.

Biosampling and longitudinal analysis

Blood and other protocol-defined samples can support CBC, coagulation, blood chemistry, cytokine, biomarker, PK/PD, and histopathology analyses. Repeated sampling may be used to follow disease induction, treatment response, and recovery when scientifically and ethically appropriate.

The sampling schedule, sample volume, processing method, and analysis plan should be established before study initiation.

Pharmacology and PK/PD

Hematology models can be integrated with pharmacology and PK/PD assessments to relate dose and exposure to bleeding control, thrombus suppression, coagulation changes, blood-flow restoration, or hematological recovery.

For biologics and other therapies that depend on species cross-reactivity, NHP studies may provide relevant pharmacological information when the target, modality, and model are scientifically appropriate.

How the hematology technologies are combined

A typical hematology study may connect several evidence streams:

  1. Hematology or vascular model: establishes bleeding, coagulation, thrombosis, anemia, blood loss, shock, or systemic inflammatory conditions.
  2. Clinical pathology: measures CBC, blood chemistry, coagulation, fibrinogen, D-dimer, and related laboratory endpoints.
  3. Functional or procedural readouts: measures bleeding time, blood loss, thrombus weight, clot dynamics, blood flow, CFR, or hemodynamic changes.
  4. Imaging and monitoring: supports DSA-guided procedures, vascular assessment, real-time flow monitoring, or physiological observation.
  5. Pharmacology and PK/PD: relates dose and exposure to hemostatic, antithrombotic, anticoagulant, or recovery effects.
  6. Integrated interpretation: connects the findings to the mechanism of action and the next development decision.

Not every project requires every technology. The appropriate combination depends on the therapeutic modality, target, model, study duration, and decision criteria.

Hematology study planning at Prisys Biotech

Prisys Biotech supports sponsors in defining the NHP model, study endpoints, technology package, and analysis plan before execution. Protocol discussion typically addresses:

  • the disease or pharmacology question;
  • the appropriate model or model combination;
  • induction or challenge method, if applicable;
  • treatment groups, dosing schedule, and study duration;
  • primary and secondary hematology or vascular endpoints;
  • CBC, coagulation, TEG, immunology, blood-flow, imaging, or PK/PD assessments;
  • biosampling, histopathology, and recovery monitoring; and
  • data analysis, reporting, and interpretation requirements.

Model availability, induction procedures, severity criteria, stopping rules, and endpoint details should be confirmed during protocol development. The final design should reflect the scientific objective and the ethical justification for NHP use.

Selected peer-reviewed studies from Prisys Biotech's hematology and hemostasis programs are listed on our scientific publications page, together with the NHP model and platform capabilities documented in each record.

Frequently asked questions

Q: What hematology models does Prisys Biotech offer?

A: Prisys Biotech's NHP hematology portfolio includes bleeding models, hemophilia A, A-V shunt thrombosis, endotoxemia, exploratory arterial thrombosis, exploratory venous thrombosis, phlebotomy-induced anemia, and acute blood loss or hemorrhagic shock.

Q: What bleeding models are available?

A: The bleeding model portfolio includes forearm vein bleeding, tail-vein bleeding, oral mucosal bleeding, Surgicutt skin bleeding, tail-tip bleeding, fingertip bleeding, and arterial bleeding procedures used in selected anemia or blood-loss studies.

Q: What endpoints can be used in an A-V shunt thrombosis study?

A: Potential endpoints include thrombus wet weight, APTT, PT, clot formation, and treatment-related suppression of thrombus formation. The study may also include PK/PD or other coagulation measurements.

Q: What is the Hybrid Folts arterial thrombosis model?

A: The Hybrid Folts model combines DSA-guided vascular injury, constrictor-induced stenosis, and real-time Transonic flow monitoring. It can be used to evaluate arterial thrombosis and the efficacy of antithrombotic or thrombolytic candidates.

Q: Can hematology studies include TEG and standard coagulation tests?

A: Yes. TEG can be combined with CBC, APTT, PT, TT, fibrinogen, D-dimer, blood chemistry, and other protocol-defined assessments. The final panel depends on the model and the mechanism of action.

Q: What is measured in an acute blood loss or hemorrhagic shock study?

A: Potential measurements include arterial pressure, heart rate, blood gas analysis, lactate, base excess, mean arterial pressure, CBC, coagulation tests, resuscitation response, and other protocol-defined physiological or survival-related endpoints.

Q: Can hematology models be combined with PK/PD and imaging?

A: Yes. NHP hematology models can integrate PK/PD, DSA, real-time blood-flow monitoring, TEG, clinical pathology, biosampling, histopathology, and other functional or pharmacological endpoints.

Discuss your hematology research program

If you are developing a hemostatic, anticoagulant, antithrombotic, thrombolytic, antihemophilic, anemia, resuscitation, or blood-loss therapy, contact Prisys Biotech to discuss the appropriate NHP model, technology package, and study endpoints.

 
 
 

Prisys Biotechnologies Co., Ltd.

Better Human Health by Primate Translational Sciences.

NHP CRO for Translational Research, PK/PD and Precision Delivery

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