Video: The Value of an Automated and Compliant-Ready Platform for Biopharmaceutical Analysis: A CRO’s Perspective

Library Number:
LITR134919046
Author(s):
Waters, Quality Assistance S.A.
Content Type:
Literature
Content Subtype:
Case Studies

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.