Christina Vessely
Biologics Consulting, USA
Biography
Christina Vessely, earned her Ph.D at the University of Colorado Health Sciences Center. has about 20 years experience in analytical and formulation development within the biotechnology industry. Her experience ranges from early stage research through late stage development and commercialization for small and large pharmaceutical companies. Areas of expertise include analytical method development and validation, development of reference standards, stability strategy and evaluation, and establishment of comparability and/or biosimilarity. Product experience includes vaccines, insulin analogs, cytokines, monoclonal antibodies, and other therapeutic proteins. She has been involved in the development and execution of CMC/Regulatory strategy for both novel and biosimilar products.
Abstract
Abstract : Analytical Assessment of Biosimilarity – Considerations in Study Design