Animal Models Development for Half-life Assay
For Research Use Only. Not for Clinical Use.
Fig.1 Generation and applications of human liver chimeric mice. (von Schaewen, 2016)
Because most therapeutic proteins suffer from poor pharmaceutical properties, a key element for the satisfactory development of novel protein drugs is to fully measure their half-life and pharmacodynamic behavior before performing clinical trials. However, many recombine proteins have complex interactions with the metabolism system, which behaves differently in human and wild animals. Therefore, humanized animal models are developed to accurately predict human drug exposure and pharmacokinetics. As a leading service provider in therapeutic proteins area, Creative Biolabs keeps up with the time and launches animal models development service for half-life assay. Our highly experienced staff can offer professional and meticulous service to accelerate your drug research process.
Introduction of Animal Models Development for Half-life Assay
Exactly measurements of drug metabolism and pharmacokinetics is key to drug discovery, especially in the field of therapeutic antibody drugs. While accurate prediction of half-life in human body shows more importance due to high in vivo degradation rate of most extrinsic proteins. While many in vitro modeling approaches exist, these simply cannot substitute for data obtained from appropriate animal models. Therefore, an urgent need exists to develop better in vivo animal models more predictive of human drug response.
The most effective means to develop half-life assay animal models is humanizing domesticated mouse strains, usually by genetic modification or organ transplantation. These humanized animals showing a metabolic system like humans act as important roles in establishment of in vivo half-life assay platform in preclinical studies. Through the validation of many groups and top journals in drug research field, lots of optimized animal models are applied in half-life assay.
Fig.2 Schematic representation of the humanized FcRn and HSA mouse model. (Viuff, 2016)
Custom Services of Animal Models Development for Half-life Assay
Creative Biolabs provides many approaches to develop comprehensive animal models for half-life assay maturely and rapidly.
- Double humanized FcRn and albumin mouse
Human serum albumin (HSA) is a natural carrier protein to prolong the half-life of many therapeutic proteins, facilitated by interaction with the human neonatal Fc receptor (FcRn). However, these metabolic system in wild mouse is different from human. With the spread using of HSA carriage and Fc fusion technology to extend half-life of protein drugs, double humanized FcRn and albumin (hFcRn+/+, hAlb+/+) mouse is widely applied to accurate predict the pharmaceutical properties and half-life of proteins which take advantage of FcRn mediated cycling in human body.
- Chimeric mouse with humanized liver
The liver plays an important role in drug metabolism due to the expression of various metabolizing enzymes. Many in vitro metabolic studies using human biological samples to simulate liver degradation such as hepatic microsomes and hepatocytes aim to predict real pharmaceutical properties in vivo. Nowadays, chimeric mice with humanized liver have been developed, in which mouse liver cells are mostly replaced with human hepatocytes and express similar enzymes. Therefore, they are regarded as suitable models for mimicking the drug half-life in humans.
In recent years, many animal models focus to half-life assay has been developed and gained satisfactory achievement. If you are interested in animal models development service for half-life assay or other kinds of custom transgenic animals, please feel free to contact us.
References
- von Schaewen, M.; et al. Generation of human liver chimeric mice for the study of human hepatotropic pathogens. Mouse Models for Drug Discovery. 2016, 79-101.
- Viuff, D.; et al. Generation of a double transgenic humanized neonatal Fc receptor (FcRn)/albumin mouse to study the pharmacokinetics of albumin-linked drugs. Journal of Controlled Release. 2016, 223, 22-30.
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For Research Use Only. Not for Clinical Use.