Lorella Di Donato

Biography

Lorella is responsible for scientific operations of Caprion’s proteomics site in Montreal, Québec. She oversees scientific and technical sample preparation/processing, mass spectrometry and bioinformatics and leads a team that provides complete offering from discovery through validation. She is also responsible for the Quality Management System (GLP) within the operation to support drug development programs (pre-clinical and clinical) for quantitative assessment of protein biomarker(s), biologics and biosimilars (PK assays). Validation of these types of assays as well as analysis of study samples are performed in accordance with FDA and EMA bioanalytical methods validation guidelines. Before joining Caprion, Lorella was Vice-President of the Analytical Operations at Cirion BioPharma Research and was responsible for technology transfer, method development and validation of biomarker, PK and immunogenicity assays to support the development of biologic and biosimilar drug products at the pre-clinical and clinical stages. Lorella received her Ph.D. in biochemistry from the University of Montréal and has over 15 years’ experience in the CRO bioanalytical area for both small and large molecules. She has extensive knowledge of regulatory requirements for more than 500 validated methods. 

Research Interest

 Bio-Analytics, Biochemistr, Bioinformatics