Prisys Biotech is a preclinical CRO specialized in translational research using non-human primates (NHPs). Leveraging its extensive experience with cynomolgus monkeys (Macaca fascicularis), Prisys provides comprehensive support for efficacy evaluation, safety assessment, biodistribution studies, and pharmacokinetic (PK) analyses, helping global partners shorten R&D cycles and enhance clinical translation success rates.
Key Capabilities
Prisys' PK studies utilize validated NHP models to evaluate drug absorption, distribution, metabolism, and excretion (ADME) across multiple administration routes. All studies are conducted under GLP-equivalent standards and IACUC-approved protocols, ensuring animal welfare and scientific reliability.
Common Dosing Routes and Sample Analysis:
- Intravenous (IV): Including bolus or slow infusion dosing to determine systemic exposure.
- Oral (PO): For assessing bioavailability and dose linearity, with multiple plasma sampling time points.
- Sample Handling: Serum or plasma samples are collected in SST or EDTA tubes, processed by centrifugation, and stored at −80°C for quantitative analysis. PK parameters such as Cmax, Tmax, AUC, T1/2, and Cl/F are calculated.
Multi-Organ Precision Drug Delivery Technology
Prisys Biotech has built an integrated Translational Delivery Technology Platform, enabling targeted drug administration and in vivo tracking in NHPs. This platform supports innovative delivery approaches for gene therapies, biologics, and CNS-targeted drugs, combining precision, imaging guidance, and reproducibility.
1. CNS-Targeted Drug Delivery
Prisys operates Asia's first intraoperative MRI (iMRI)–guided brain navigation and delivery system, integrating CT, DSA, and ultrasound-assisted interventions to achieve real-time, image-guided precision dosing.
iMRI-Guided CED (Convection-Enhanced Delivery): Enables direct intraparenchymal infusion of compounds (e.g., viral vectors, biologics) into specific brain regions such as the putamen or thalamus using ClearPoint® Navigation and SmartFlow® cannula systems.
Blood-Brain Barrier Bypass: Direct brain infusion maximizes local exposure and minimizes systemic load.
Real-Time Visualization: iMRI provides submillimeter accuracy and immediate verification of delivery location and spread.
CSF Sampling & PK Analysis: Repeated CSF sampling allows comprehensive PK and PD correlation studies.
2. Nose-to-Brain (N2B) Delivery
Prisys is developing intranasal-to-brain administration protocols for improved CNS bioavailability.
Imaging Validation: Delivery paths verified via CT/MRI contrast imaging using agents such as iohexol or barium sulfate.
Functional Assessment: fMRI studies have shown region-specific effects (e.g., amygdala and hippocampal perfusion changes following intranasal insulin administration).
Device Optimization: Evaluation of NHP dry powder system for nasal drug deposition efficiency.
3. Pulmonary Drug Delivery
Prisys provides specialized respiratory drug delivery and inhalation PK models for pulmonary disease research.
- Intratracheal Administration: Using high-pressure micro-sprayers for localized lung deposition.
- Aerosol Inhalation: Utilizing Aerogen Solo® nebulizers integrated with NHP ventilators for precise dosing.
- Bronchoscopic Delivery & BALF Sampling: Prisys facilities are equipped for bronchoscopic administration and bronchoalveolar lavage fluid (BALF) collection for PK/PD correlation.
4. Ocular Targeted Delivery
Prisys supports ophthalmic studies involving intravitreal injection (IVT) and ocular PK evaluation.
Example: IVT administration of sodium iodate for retinal degeneration (RP) model induction and drug response evaluation.
5. Other Image-Guided Organ Delivery
Prisys also offers DSA-guided targeted organ perfusion and ultrasound-guided survival biopsies for PK tissue sampling (e.g., hepatic biopsy at 48h and 168h post-dose), enabling temporal tissue-level drug distribution analysis.
Why Choose Prisys Biotech
Cynomolgus Monkey Expertise: Decades of experience in NHP pharmacology and translational modeling.
Advanced Imaging Platforms: iMRI, CT, DSA, and ultrasound-guided interventions for precision drug delivery.
Integrated PK-PD Analysis: Full-spectrum bioanalytical and pharmacometric capabilities.
High Translational Relevance: NHP data that closely mirror human pharmacokinetic and pharmacodynamic profiles.
FAQs
Q1: Why are cynomolgus monkeys preferred for PK studies?
A: Their close physiological similarity to humans provides highly predictive pharmacokinetic and metabolism data, critical for translational drug development.
Q2: What types of drug delivery routes can Prisys support?
A: Prisys supports intravenous, oral, intranasal, intrathecal, intravitreal, bronchoscopic, and image-guided organ perfusion routes.
Q3: Can Prisys conduct GLP-compliant PK studies?
A: Yes. Prisys' facilities and protocols are GLP-equivalent and follow IACUC and international ethical guidelines.
Q4: How are PK samples analyzed?
A: Serum, plasma, CSF, or tissue samples are analyzed using validated LC-MS/MS or ELISA assays, followed by pharmacokinetic modeling via WinNonlin.
Q5: What therapeutic areas benefit most from Prisys' precision delivery capabilities?
A: CNS, respiratory, and ophthalmic drug development, particularly gene therapies, biologics, and CNS-targeted agents.
