In the realm of preclinical research, nonhuman primates (NHPs) play a pivotal role due to their genetic, immunological, and physiological similarities to humans. However, the high cost and limited availability of these animals pose significant challenges. Prisys Biotech offers an innovative solution: the utilization of non-naïve NHPs, also known as "used animals," which have previously been subjected to drug treatments. This approach not only reduces costs but also makes immediate use of available animals.
The Benefits and Challenges of Using Non-Naïve NHPs
Using non-naïve NHPs, especially those previously exposed to protein therapeutics such as monoclonal antibodies, ADCs, fusion proteins, or peptides, presents both opportunities and challenges. Here's a closer look at what Prisys Biotech has identified:
- Cost-Effectiveness: Non-naïve NHPs can cost half as much as naïve animals, significantly reducing research expenses.
- Immediate Availability: These animals are often readily available, unlike naïve NHPs which may require lengthy procurement times.
- Ethical Considerations: Reusing animals aligns with the 3Rs principle (Replacement, Reduction, and Refinement) in animal research, promoting ethical practices.
However, the use of non-naïve NHPs is not without its hurdles. Key challenges include the potential for hypersensitivity reactions, residual pharmacological effects, and regulatory concerns. To address these, Prisys Biotech adheres to stringent criteria and rigorous screening processes.
Example decision tree for inclusion of protein non-naïve NHPs in subsequent studies with therapeutic proteins.
Screening and Selection Criteria
Prisys Biotech follows a comprehensive decision-making process to ensure the suitability of non-naïve NHPs for specific preclinical trials. The process involves:
- Baseline ADA Screening: Assessing for anti-drug antibodies (ADAs) to minimize the risk of hypersensitivity.
- Pharmacological Sensitivity Screening: Evaluating the animal's responsiveness to new drug candidates.
- Washout Periods: Implementing adequate washout periods to mitigate residual effects from previous treatments.
- Clinical Pathology Monitoring: Ongoing health assessments to ensure the animals are fit for new studies.
Applications of Non-Naïve NHPs
Non-naïve NHPs can be effectively utilized in various research contexts, including:
- Exploratory Research: Developing preclinical models and tissue harvesting for in vitro studies.
- Toxicology and Safety Pharmacology: Conducting dose-range finding (DRF) studies and single-dose toxicity assessments.
- Pharmacokinetics (PK) and Pharmacodynamics (PD): Used in non-critical, non-GLP (Good Laboratory Practice) studies.
Industry Insights and Best Practices
Prisys Biotech is actively involved with the IQ Consortium NHP Reuse Working Group, which surveyed 15 pharmaceutical companies, including industry leaders like AbbVie, Novartis, and Merck. The survey revealed that while the majority support using non-naïve NHPs under specific conditions, concerns about hypersensitivity and regulatory rejection persist. Therefore, it is crucial to establish reliable ADA testing methods and maintain meticulous health records.
Conclusion
Prisys Biotech's strategic approach to utilizing non-naïve NHPs in preclinical trials offers a viable solution to the challenges of high costs and limited animal availability. By implementing rigorous screening protocols and adhering to industry best practices, Prisys Biotech ensures the ethical and effective use of these animals, ultimately advancing the field of preclinical research.
For more information on Prisys Biotech's services and their commitment to innovative, cost-effective research solutions.
[1] Int J Toxicol. 2022 Aug;41(4):291-296. doi: 10.1177/10915818221101791. Epub 2022 Jun 2.
