Ensuring the safety and efficacy of biotherapeutics from research to development, and then from manufacturing to quality control is essential to bring a product to market. Large molecules pose unique challenges for biotherapeutic analyses in that they often require running a panel of tests to ensure product efficacy and safety.
Industry efforts have evolved towards comprehensive analytical workflows that enable researchers to monitor critical quality attributes (CQAs) of highly complex and diverse biotherapeutic molecules.
Part 1: Introduction to Workflows
This presentation will provide an insight into the basics of the biopharma industry and introduce how analytical tools can be utilised as part of comprehensive workflows for characterisation of CQAs.
Biopharma Market Specialist EMEA IDO
Donna is a Biopharma Market Specialist for Agilent Technologies; over the last decade she has been responsible for business development for Agilent analytical solutions in the Biopharma market space. Donna has worked extensively with biomolecules during her career, with a strong emphasis on Life Science and Biopharma applications using LC-MS.
After completing Postdoctoral Research at Boston University School of Medicine, she worked as an application specialist before becoming a Market Specialist in 2013. Donna holds a PhD in Analytical Chemistry from The University of Manchester, UK, where her studies focused on protein quantitation using mass spectrometry.
Product Specialist, EMEA IDO – Chemistries & Suppliers
With more than 20 years of professional experience, Cecilia is presently the Product Specialist for columns and supplies at Agilent. Supporting distributors and laboratory users in the analysis and purification of small and large molecules, for a wide range of LC and GC applications as well as sample preparation.
Cecilia holds a Ph.D. in Chemical Engineering from Rensselaer Polytechnic Institute in US.