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Non-Human Primate (NHP) Microsomal & Hepatocyte Stability Assay Service
Are you currently facing challenges with unpredictable in vitro-to-in vivo metabolic data, leading to costly and time-consuming failures in late-stage development? Our NHP Microsomal & Hepatocyte Stability In Vitro DMPK Assays help you obtain highly predictive metabolic stability data and identify potential liabilities early. Through advanced in vitro assay systems and expert bioanalytical services, we provide a clearer, more accurate view of how your compound will behave in the body, de-risking your journey to the clinic.
Introduction to NHP Microsomal & Hepatocyte Stability Service
What Our Service Is
Our in vitro assays are designed to assess the metabolic stability of a drug candidate by measuring the rate at which the parent compound is cleared by liver enzymes. We utilize high-quality, cryopreserved liver fractions from non-human primates, which are the industry gold standard for translational research. These assays are invaluable for:
- Lead Compound Selection: Quickly screening and ranking a large number of compounds to identify those with the desired stability profile.
- Prediction of In Vivo Clearance: Generating data that can be scaled to accurately predict a compound's half-life and hepatic clearance in both NHPs and humans.
- Metabolic Liability Identification: Pinpointing potential issues, such as rapid metabolism, that can be addressed through medicinal chemistry optimization.
Why Choose Us?
Many drug discovery projects face a critical gap in data, as metabolic information from rodent models often fails to translate to humans. This can lead to unexpected toxicity or a lack of efficacy during clinical trials. Creative Biolabs' NHP assays bridge this gap by providing a more reliable and human-relevant model. By leveraging the genetic and physiological similarities between NHPs and humans, we help you overcome the pain point of unpredictable metabolism, saving valuable time and resources. Our solutions provide the confidence you need to advance your most promising candidates.
Fig.1 In vitro stability assessment of YZG-331 in liver microsomes from humans, dogs, monkeys, mice, and rats.1
Key Benefits of Our Service
Creative Biolabs' Non-Human Primate In Vitro DMPK Assays offer a significant competitive advantage. We provide a tailored, high-quality service that goes beyond a standard protocol to meet the unique needs of your project.
- Unparalleled NHP Resources: We maintain a large, diverse inventory of high-quality cryopreserved liver microsomes and hepatocytes from various NHP species, including Cynomolgus and Rhesus monkeys, ensuring we can select the most appropriate model for your specific needs.
- High-Speed Response: We are committed to an agile and responsive service model. Our streamlined processes and dedicated team ensure a fast turnaround time from sample receipt to data delivery, accelerating your decision-making.
- Deep Customization: Every project is unique. Our scientific team works closely with you to design a custom assay protocol, including optimizing substrate concentrations, species, and incubation time points, ensuring the data generated is directly relevant to your research questions.
- Exceptional Reporting Depth: Our comprehensive reports provide more than just raw numbers. We deliver detailed data analysis, clear graphs, and expert interpretation from our scientists, giving you a complete understanding of your compound's metabolic fate.
How Creative Biolabs' Assays Can Assist Your Project?
Workflow
01
Required Starting Materials
02
Project Consultation
03
Protocol Design & Approval
04
Experimental Execution
05
Bioanalytical Analysis
06
Data Processing & Reporting
Key Deliverables
- Comprehensive Lab Report: A detailed document summarizing the experimental design, methodology, and results.
- Raw Data Files: Complete raw data from the UHPLC-MS analysis, ensuring full transparency.
- Calculated Parameters: Half-life and apparent intrinsic clearance values.
- Graphical Data: Visual representations of parent compound depletion curves.
- Expert Commentary: Our scientific team's interpretation of the data and its implications for your project.
Capabilities & Partnerships
Service-Specific Data
- Annual Sample Size: Over 50,000 compounds
- Typical Turnaround Time (TAT): 10-15 business days
- Assay Pass Rate: >98%
Our Valued Partners
Frequently Asked Questions
Q: Why are Non-Human Primate assays so important in drug discovery?
A: NHP in vitro assays are crucial because NHPs share a high degree of genetic and metabolic similarity with humans, particularly in their CYP enzyme profiles. This makes NHP data more predictive of human outcomes compared to data from other preclinical species, which is essential for de-risking your program before entering clinical trials.
Q: How do I know whether to use a microsomal or hepatocyte assay for my compound?
A: The choice depends on the project stage and compound properties. Microsomal assays are ideal for rapid, high-throughput screening of Phase I metabolism in early discovery. Hepatocyte assays, as a whole-cell system, are more comprehensive and provide a more accurate picture for compounds with significant Phase II metabolism or those that are actively transported into cells. We can discuss your compound and recommend the best approach during our consultation.
Q: My compound has low solubility. Can you still perform the assay?
A: Yes. We have extensive expertise in handling challenging compounds. Our scientists can optimize the assay protocol, including the use of specific co-solvents and specialized incubation conditions, to ensure accurate and reliable data even for poorly soluble compounds.
Q: What specific data and insights will I receive in the final report?
A: You will receive the half-life and intrinsic clearance values, presented in an easy-to-read format. Our comprehensive report also includes an expert summary that analyzes the data, highlights any potential metabolic liabilities, and provides actionable recommendations to guide your next steps.
Q: How does your service compare to conducting these assays in-house?
A: Our service provides a cost-effective and time-saving alternative to in-house labs. By partnering with us, you gain immediate access to our specialized NHP resources, advanced analytical equipment, and a team of seasoned scientists, all without the significant capital investment and operational overhead.
Contact Us
Creative Biolabs is a trusted partner for in vitro DMPK and drug metabolism studies. Our Non-Human Primate Microsomal & Hepatocyte Stability Assays provide the predictive, human-relevant data you need to make critical decisions and accelerate your drug development journey with confidence. To learn more about our services or to discuss your specific project needs with our experts, please reach out to us. We are here to help you succeed.
Reference
- Liu, Zhihao, et al. "Interspecies variation of in vitro stability and metabolic diversity of YZG-331, a promising sedative-hypnotic compound." Frontiers in pharmacology 8 (2017). Distributed under Open Access license CC BY 4.0, without modification. DOI: https://doi.org/10.3389/fphar.2017.00527