SNBL Preclinical Services
SNBL preclinical operations are based at our laboratories, located in Kagoshima and Wakayma, Japan. Preclinical studies are an important part of our drug development research, from screening novel compounds to confirming the safety and efficacy of pharmaceuticals. GLP studies are essential for application to applicable regulatory authorities. With our experienced teams and full-service laboratories, we can custom design a study that is right for most compounds, offering studies described following:
- Safety studies (including general toxicity studies, reproductive and developmental toxicity studies, genotoxicity studies, and local irritation studies)
- Safety pharmacology studies
- Pharmacology studies
- Pharmacokinetic studies
The Wakayama SNBL Pharmacokinetics and Bioanalysis Center (PBC) offers establishment and validation of analytical methods, analysis of biological samples, and calculation of pharmacokinetic parameters by expert researchers using state-of-the-art equipment. We are able to expertly analyze a number of compounds such as test articles and metabolites in samples, and have conducted more than 8000 studies, by chromatography assay using HPLC, LC-MS/MS, ICP-MS, by ligand binding assay using Gyrolab xP workstation, Meso QuickPlex SQ120, and other instruments. The SNBL PBC can propose the most suitable study design according to client drug development needs, including small, middle, and large molecules.
The SNBL PBC can analyze both preclinical (several kinds of animals) and clinical (Phase I to IV) study samples (plasma, urine, various body fluids, and tissues) in compliance with GxP regulations.
Gyrolab Platform Services at SNBL
We have been using Gyrolab xP workstation for 7 years to provide commercial services. We offer a broad range of pharmacokinetics analysis and toxicokinetics analysis for biotechnology-based pharmaceuticals including antibody, oligonucleotide, protein, and peptides etc., in biological samples (plasma, serum, urine, etc.) from mouse, rat, monkey, and human.
Advantages of Gyrolab Platform Immunoassays:
- The required sample volume for analysis is small.
- Analytical operations can be automated.
- It is possible to develop analysis methods and analyze samples in a short period.
We choose Gyrolab when high throughput and high sensitivity analysis methods are necessary.
Investing in Gyrolab Platform for the Future
SNBL originally invested in Gyrolab platform to advance our automation of LBA analysis methods. Gyrolab enabled us to improve our measurement accuracy and reliability over other platforms which had high background signal and poor sensitivity.
The pace of drug development is accelerating, and there is a need to rapidly obtain accurate bioanalysis data. Gyrolab is a powerful tool for increasing the throughput of bioanalysis using immunoassays.
For more information, visit the SNBL website.