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Creative Biolabs: Your NHP-based safety assessment expert!

Safety assessment is an essential part of preclinical research to test the potential toxicity of new drug candidates before being exposed to the human body. At Creative Biolabs, our toxicity research segment is powered by multidisciplinary specialists and easy-to-access preclinical facilities all over the world, which will ensure your drug's potential toxicity is best characterized. With rich preclinical drug development experience, you can always trust our team will reward you with reliable safety assessment results.

What Services We Can Provide

Given the uniqueness of each project, our safety assessment services are designed in multiple types to flexibly match your specific needs. Tell us more experimental details and we will offer you a more applicable scheme and a more precise timeline estimate.

• Drug Discovery Toxicology

Drug discovery toxicology is aimed at testing the toxicity of compounds at the early stage of drug development so that researchers can identify the potential risks and make more effective decisions for better avoiding late-stage research failures. Generally, we carry out this study in different time points or different primate groups through oral or intravenous injection to explore the adverse effects on monkeys.

• Systemic and Organ-specific Toxicity

Available systemic and organ-specific toxicity services

• Investigative Toxicology

The purpose of investigative toxicology research is to test the mechanistic toxicopharmacology of the compound candidate. By an administration route diverse from the intended clinical route, we conduct this study in combination with genetic, physiological, and pharmacological assessment results.

• Immunotoxicology

Immunotoxicology is widely applied in scenarios when researchers need to explore the immune-specific effects of drugs. In this study, immune biomarkers and immunophenotyping will be evaluated using. Detailed experiment design can be determined by your specific requirements, such as whether a recovery phase is necessary.

• DART

Developmental and reproductive toxicity (DART) study involves the harmful effect evaluation on the normal development of embryos, fetuses, and reproductive systems. At Creative Biolabs, we have developed a suite of unique techniques to ensure the smooth execution of your primate DART studies related to fertility and early embryonic, embryonic development, prenatal and postnatal development, and juvenile toxicity.

• Safety Pharmacology

Whether core battery or supplemental studies, Creative Biolabs can respond quickly to your experimental needs. We have built a powerful specialist team and are committed to providing extensive safety pharmacology research services including the safety evaluation of the central nervous system, respiratory system, and cardiovascular system or the in vitro hERG assay.

Why Partner with Creative Biolabs

Choose Creative Biolabs and you will gain a partner with specialized safety assessment experience to perform your studies efficiently and in compliance, ensuring that your project is on schedule. Please contact us timely for more information if you are interested in our NHP-based safety assessment services.

Published Data

The article "NHP Based Safety Assessment" primarily focuses on evaluating the immunogenicity of biopharmaceuticals, specifically monoclonal antibodies (mAbs), in the context of non-human primate (NHP) models. The study underscores the challenges in drug development related to predicting human immune responses based on NHP data, a concern arising from notable species differences.

A significant portion of the research involves a comparative analysis of the immunogenic response to mAbs in NHPs versus humans. It was found that the incidence of anti-drug antibody (ADA) formation was comparable between NHPs and humans in only 59% of the cases, and in the same percentage of cases, the type of ADA response differed between the two species. Humanization of mAbs did not consistently reduce their immunogenicity in humans, indicating that this modification alone is not a foolproof method to mitigate immune responses.

The research also highlights that the presence of ADAs in NHPs could influence the pharmacokinetic and pharmacodynamic profiles of mAbs, thus impacting the safety assessment process. It concludes that while NHPs are valuable in mAb development, the predictability of human immune responses based on NHP data is limited, due to species differences and the variable nature of immunogenicity.

This study emphasizes the importance of considering species-specific responses in drug development and the need for cautious interpretation of NHP data when extrapolating to human contexts.

Table.1 Incidence and response level, either clearing or neutralizing, of anti-drug antibodies in non-human primates

Table.2 Immunogenicity in non-human primates vs. human

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