一款满足合规要求的自动化平台对于生物制药分析而言的价值：从CRO公司视角观察
Belgium-based Quality Assistance S.A. provides the pharmaceutical and biopharmaceutical industry with CRO analytical services required for FDA-, EMA-, PMDA-, and ANVISA-compliant drug development. These include services ranging from candidate selection through non-clinical and clinical studies to marketing authorization.
Quality Assistance has grown annually at about 10 percent per year and set a goal of assisting 500 innovative drug molecules through development by 2020. To do so, it requires continuous deployment of cutting-edge technologies, particularly for biologics, which have increased to roughly half of its business.
The CRO has deployed compliant-ready Waters Biopharmaceutical Platform Solution with UNIFI which helps them to perform high resolution UPLC-MS-based analyses – intact protein, peptide mapping, and released glycan analysis – for the characterization and monitoring of biopharmaceutical product quality attributes.
“With the Waters Biopharmaceutical Platform Solution with UNIFI, we are able to provide a full package and to fully characterize the product of our customers and to provide them very accurate results.” –Arnaud Delobel*, Scientific Manager, Biologics, Quality Assistance
“A single platform means that we can control the LC and MS apparatus as well as process the data and report on this data with a single software, which makes everything much faster and easier than it was before where we had to use different software if you perform all of these tasks.” –Eric Largy, R&D Scientist, Quality Assistance
Watch the following video for the full story:
To read the companion case study, click here.
*Since the release of this video, Arnaud Delobel was promoted to R&D Director, Quality Assistance.
