Non-Human Primate (NHP) Bioanalytical & Biomarker Analytics

Are you currently facing long drug development cycles and challenges in obtaining high-quality preclinical data to support your biologics? Our NHP Bioanalytical & Biomarker Analytics Platforms help you accelerate drug discovery and streamline preclinical processes by providing high-predictability data through advanced analytical platforms and strategic study design. Our innovative approach minimizes preclinical uncertainty, allowing you to make informed decisions and accelerate your path to the clinic.

Advanced NHP Bioanalytical & Biomarker Analytics Platforms for Preclinical Studies

Enabling precision PK/PD and safety evaluation in non-human primate models.

Overview of NHP Bioanalytical & Biomarker Analytics Platforms

What Are Our Platforms?

Our comprehensive service offerings provide a powerful suite of bioanalytical and biomarker platforms designed to support the preclinical development of biologics, with a specific focus on non-human primate (NHP) models. This service provides quantitative and qualitative analysis of drug candidates, as well as the measurement of key biomarkers to assess drug efficacy and safety. We leverage a wide range of state-of-the-art technologies to support successful IND submissions and other application scenarios:

Why Choose Our Platforms?

Bringing a new biologic to market is a complex and capital-intensive process. A significant challenge in the preclinical phase is obtaining data that is highly predictive of human outcomes, especially given the high specificity of biologics like monoclonal antibodies (mAbs). Traditional reliance on extensive NHP cohorts can lead to logistical and ethical challenges, as well as prolonged timelines.

At Creative Biolabs, we create value by directly addressing these pain points. Our platforms are designed to reduce research and development uncertainty by generating high-quality, reproducible data that is essential for guiding your development strategy. Our strategic approach integrates advanced analytical capabilities with smart study design, allowing you to maximize data yield from each study.

Comprehensive catalog of RNA genes and proteins in rhesus monkey blood. (OA Literature) Fig.1 Complete catalog of RNA genes and proteins in rhesus monkey blood.¹

Key Benefits of Our Platforms

High-predictability results: Data highly predictive of human outcomes.
Supports multi-platform integration: Combines PK, PD, and safety endpoints in a single study.
Rapid project initiation: Flexible customization for rapid study design and execution.
Data supports IND submission: High-quality, reproducible data for regulatory filings.

Core Capabilities of Our Platforms

LC-MS/MS & HR-MS Small Molecule Quantitation: Precision quantification of small molecules in complex biological matrices, essential for preclinical ADME and PK studies.
Large Molecule & Protein Analysis (ELISA, MSD): High-sensitivity quantification of large molecules like biologics and proteins, crucial for PK and immunogenicity assays
ADA & Neutralizing Antibody Assays: Accurate assessment of anti-drug antibodies (ADA) and their neutralizing potential to determine immunogenicity.
Cytokine/Chemokine Multiplex Profiling: Simultaneous quantification of multiple cytokines and chemokines to provide a comprehensive profile of a drug's immune-modulating effects.
Histology, IHC/IF & In Situ Hybridization: Detailed visualization of tissue morphology and protein or gene expression, providing a deep understanding of target engagement and off-target effects.
Integrated Multi-Omics Data Reporting: Streamlined integration and analysis of multi-omics datasets for a holistic view of a drug's mechanism of action and its effects on the biological system.

Applications Enabled

Biomarker Analysis for PKPD Studies: Our platforms enable the precise measurement of pharmacodynamic biomarkers to establish a clear concentration-effect relationship for your biologic, which is a key component of a successful preclinical program.
Safety Pharmacology & Toxicology Assessments: We provide a comprehensive suite of analytical services to identify potential safety concerns, supporting critical toxicology studies and helping to de-risk your biologic before it enters the clinic.
Immunogenicity Risk Assessment: Our specialized assays for ADA and neutralizing antibodies allow you to comprehensively assess the immunogenicity risk of your biologic, providing valuable insights for clinical trial design.

Deliverables

Processed datasets (e.g., biomarker panels, raw data files)
Study report with methodology, results, and summary
Statistical analysis summary & raw data files
QC logs & metadata (species, donor info)

Frequently Asked Questions

Q: What is the typical turnaround time for a bioanalytical study?

A: Turnaround time is highly dependent on the complexity of the study, but our streamlined process and flexible customization options are designed for efficiency. We work closely with you from the outset to establish a timeline that meets your project's needs.

Q: How do you ensure the quality and reproducibility of your data?

A: We adhere to rigorous quality control standards and employ validated analytical methods on state-of-the-art platforms. Our detailed deliverables include comprehensive QC logs and metadata, ensuring full transparency and data reproducibility.

Q: Can you help with custom biomarker panels that are not listed?

A: Absolutely. Our team of expert scientists has extensive experience in developing and validating custom assays for unique biomarkers. We specialize in creating custom panels to meet the specific requirements of your research.

Q: How do your platforms compare to traditional in-house lab methods?

A: Our platforms offer several key advantages, including access to a wider range of advanced technologies (e.g., LC/MS), specialized expertise in NHP models, and integrated data reporting. This allows for a more comprehensive and efficient study, ultimately providing more predictive data for your program.

Q: What is the minimum sample volume required for your assays?

A: Sample volume requirements vary by assay, but we have optimized our methods for high sensitivity to minimize the volume needed. We encourage you to contact us to discuss the specifics of your samples and project goals.

Contact Us

Creative Biolabs is your strategic partner in preclinical development, providing a sophisticated blend of scientific knowledge and innovative technology to accelerate your biologic's path to the clinic. Our NHP Bioanalytical & Biomarker Analytics Platforms are engineered to provide high-quality, predictive data that de-risks your project and builds the foundation for a healthier future. Ready to leverage our NHP Bioanalytical & Biomarker Analytics Platforms for your next study? Contact Our Team for More Information and to Discuss Your Project.

Reference

Liu, Yunpeng, et al. "Analysis of the aging-related biomarker in a nonhuman primate model using multilayer omics." BMC genomics 25.1 (2024): 639. Distributed under Open Access license CC BY 4.0, without modification. DOI: https://doi.org/10.1186/s12864-024-10556-z