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Creative Biolabs: Your NHP-based in vivo pharmacokinetics (PK) expert!

When it comes to API's effectiveness and safety assessment, an in vivo pharmacokinetics (PK) study should be conducted to explore the characteristics of absorption, biodistribution, metabolism, and excretion of drugs, which can help researchers make a correct decision on drug dose. At Creative Biolabs, we provide a full suite of non-human primate (NHP) based in vivo PK services to address the great demand from clients. We understand every program is unique and thus all these assays can be customized upon your specific request.

What Services We Can Provide

At Creative Biolabs, our in vivo PK services have covered almost all the research types you may need. Our experienced research team will design the best matching solution for your project, ensuring your PK research produces precise and reproducible data.

• Standard PK

Standard PK research aims to evaluate the oral bioavailability, exposure level, and half-life of the candidate compound by quantifying the drug level at different time points within 24 hours of single-dose administration. The dosing approaches and blood-derived sample types can be selected according to the need.

• Specialized PK

Our specialized PK services comprise multiple well-designed experiments and allow you to assess the ADME features of the test protein or compound and dose-related PK properties.

The categories of Creative Biolabs' specialized PK services

• Drug Tissue Distribution

Creative Biolabs offers the drug tissue distribution assay, which means measuring the drug level in the specific tissue by analyzing the biopsies or microdialysis samples of NHPs in the conduction course of standard PK or specialized PK research. You can choose to carry out your own sample analysis or delegate the whole research to us to get a full report.

• Enzyme Induction

If you would like to find out whether and how the compound affects the liver enzymes, please select our enzyme induction service. Our team compares the PK profiles of drugs at different points on the day and the last day of administration to collect evaluable enzyme induction information for you.

• Enzyme/Transporter-mediated DDIs

The influence of physiologically related enzymes and transporters on drug-drug interactions (DDIs) is assessed through the co-administration of a probe substrate cocktail with the test drug. Additionally, using certain inhibitors to identify metabolic pathways is also feasible during standard PK research.

Why Partner with Creative Biolabs

As a pioneer in NHP research, Creative Biolabs constantly promotes our expertise in this field and has surpassed our competitors in many ways. We appreciate your unique vision in choosing us and will repay you with the best services. Feel free to contact us if you have any problems.

Published Data

The article is a detailed examination of the pharmacokinetics of Fc-engineered monoclonal and multispecific antibodies in non-human primates (NHPs), specifically in cynomolgus monkeys. This study is critical for understanding how these antibodies behave in a system closely resembling human physiology, providing essential insights for therapeutic development. The focus on Fc modifications and their impact on factors like antibody half-life and clearance is a significant part of the research, illustrating the importance of NHP models in bridging preclinical and clinical study gaps.

The use of NHPs in this context is particularly relevant because of their genetic and physiological similarities to humans, making them an invaluable model for predicting human pharmacokinetic responses. This study not only sheds light on the pharmacokinetics of Fc-engineered antibodies but also highlights the nuances in antibody design that can optimize their effectiveness and safety in human treatments. By comparing the findings from NHP models with those from humanized FcRn transgenic mouse models, the research underscores the unique advantages of using NHPs in pharmacokinetic studies, especially for drugs targeted for human use.

Figure 1. Comparison of pharmacokinetic profiles in cynomolgus monkeys and homozygous Tg32 and Tg276 mice following administration of (a) mAb1-WT or (b) with the LS mutation; (c) tri-Ab6-WT or (d) with the LS mutation. For mouse studies, pooled plasma samples were plotted per sampling time. Abbreviations: ADA = anti-drug antibody, mAb = monoclonal antibody, tri-Ab = trispecific antibody, WT = wild type.

Figure 2. Comparison of pharmacokinetic profiles in (A/C) Tg32 mice and (B/D) cynomolgus monkeys. Administration of (A/B) FcRn-modulating LS and YD mutations; (C/D) mAb1 or mAb3, WT and mutated Fc backbones, Fc-silencing FcγRIIIa (NNAS). Abbreviations: mAb = monoclonal antibody, WT = wild type.

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