Christina Vessely, PhD

Christina Vessely, PhD

Senior Consultant

Christina Vessely, PhD comes to Biologics Consulting with over 18 years of experience in analytical and formulation development within the biotechnology industry. Her experience ranges from early stage research and development for small and start-up firms through late stage development and commercialization for mid-sized and large pharmaceutical companies. She has been involved in priority review and/ fast track programs, she has participated in Pre-approval inspections (PAI) and PAI enabling activities such as design and execution of validation studies and evaluation of GMP systems, as well as authoring and editing of analytical sections for multiple filings in both the U.S. and in the EU (IND/IMPD, BLA/MAA).

In the analytical arena, Christina’s areas of expertise have included analytical method development and validation, development of reference standards and other critical reagents, stability strategy and evaluation, and establishment of comparability and/or similarity. Her 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.

Christina earned her PhD at the University of Colorado Health Sciences Center (now CU Denver). She studied in the laboratory of Dr. John Carpenter, where she utilized various biophysical and biochemical techniques for the characterization of proteins. Through various projects within the biotechnology industry she has expanded her formulation development experience to include therapeutic proteins (including monoclonal antibodies), both liquid and lyophilized, for both traditional and non-traditional delivery systems. She additionally has worked with vaccines and with peptide based therapies. In addition to her PhD, she holds a MS in Chemistry from CU Denver and a BS in Chemical Engineering from the Colorado School of Mines in Golden, CO.

As a Senior Consultant in Analytical and Formulation, Christina will utilize her expertise to assist clients in the following areas:

  • Development, Qualification and validation of analytical methods for raw materials, In-process testing, Lot release, Stability, and assessment of comparability and similarity
  • Application of Biophysical and Biochemical techniques for extended characterization of products and to further demonstrate comparability and biosimilarity. Techniques include various spectroscopic techniques, evaluation of thermal properties, and evaluation of sub-visible particles
  • The development and characterization of critical reagents including product specific reference standards, assay specific reagents, and strategy to demonstrate continuity of standards across the life span of the program
  • Formulation strategy and development including the design of preliminary and later stage screening studies, application of biophysical techniques to evaluate formulation stability for short term studies, evaluation of stability profiles for lead candidate formulations in longer term studies, and evaluation of container/closure systems for drug substance and drug product

Education

PhD, Pharmaceutical Sciences University of Colorado Health Sciences Center, Denver, CO (2006)

MS, Chemistry, University of Colorado, Denver, CO (2002)

BS, Chemical Engineering, Colorado School of Mines, Golden, CO (1996)