“Provided assay sensitivity is sufficient then Gyrolab is our first choice.”

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CPhS conducts quantitative analysis of biopharmaceuticals in biological samples using the best methods and platforms available to solve individual tasks and this lead to the acquisition of Gyrolab system three years ago after having identified a number of advantages for bioanalytical projects:

  • High-quality (accuracy and precision) data with reduced matrix effects
  • Simplified assay workflows and shortening run time
  • An open platform with high flexibility which enables easy development of custom assays
  • Limited operator training requirements, which smoothens assay transfer from sponsors

Since they acquired Gyrolab system, the system has proven itself time and time again, with high throughput, low background, easy method transfer from sponsors, and low intra-operator and inter-operator variation. As researchers at the Bioanalysis Research Department say, “If we have sufficient sensitivity in the assay, we would like to use Gyrolab as the first choice.” The introduction of Gyrolab system into their US lab has enabled them to transfer assays between their facilities in Japan and the USA. They are pleased with the rapid support that Gyros Protein Technologies always provides. Looking into the future, the CRO expects that the demand for biosimilars will increase, demanding higher throughput that they expect to meet using Gyrolab system.

Company presentation

CMIC Pharma Science Co., Ltd. presents themselves

CMIC Pharma Science Co., Ltd. (CPhS) is a member of CMIC group and a non-clinical CRO that provides appropriate solutions on various issues of product development and lifecycle for sponsors related to life science. CPhS is the core company of non-clinical areas in CMIC group, the first CRO in Japan and one of the major CROs in the world. We work closely with other companies in Japan, other Asian countries, and the USA to promote our comprehensive strength to the world.

CPhS includes three laboratory sites. Firstly, Kobe Laboratory conducts bioanalysis, including analysis of drug concentrations in biological specimens and analysis of biomarkers, of pharmaceutical products. Secondly, CMIC Bioresearch Center located in Hokuto city, Yamanashi, conducts pharmacological efficacy studies, safety pharmacology studies, toxicity studies, etc. that evaluate the efficacy and safety of pharmaceutical products, medical devices, chemical substances, and foodstuffs. Lastly, Sapporo Laboratories performs CMC studies including stability testing, sample storage studies, quality testing, and release tests. These solution services in non-clinical areas have been gaining trust from sponsors for many years as a top brand in Japan.

Our efficient and effective solutions can meet the needs of sponsors by not only complying regulations such as GMP, GLP and Reliability Criteria for Application Data (a Japanese regulation) as one of the largest contract laboratories in Japan but also establishing global quality management system that meets global requirements of overseas inspection agencies such as FDA and global GMP standards such as PIC/S.

In the Kobe laboratory, we can conduct analysis of pharmaceuticals including biologics in biological samples by utilizing various kinds of high-end assay instruments such as LC-MS/MS, ECL, ELISA, and Gyrolab system in compliance with GLP. As for solutions to meet biomarker analysis, we have excellent experience with FCM and qPCR in addition to the above instruments.

http://www.cmic-phs.com