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Christina R Vessely

Christina R Vessely

    PhD
Senior Consultant | Alexandria, Virginia    United States Of America
Biotechnology
Biotechnology, Analytical Development,...More
Spoken at 2 events

Biography :

Dr. Vessely comes to BCG with over 17 years of experience in the areas of analytical and formulation development within the biotechnology industry. Her work 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. Her most recent industry experience was focused on commercialization of a monoclonal antibody for which the FDA had granted fast track status. The work included Pre-approval inspection (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). The projects provided an opportunity to participate actively in agency interactions, including PAI and other inspections, and responding to agency questions related to filings.

Christina earned her Ph.D. 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. Her thesis work included formulation development for a multivalent vaccine against Botulinum Neurotoxin. Through various projects within the biotechnology industry she has expanded her formulation development experience to include therapeutic proteins, both liquid and lyophilized, for both traditional and non-traditional delivery systems.

In addition to her Ph.D, she holds a M.S. in Chemistry from CU Denver and a B.S. in Chemical Engineering from the Colorado School of Mines in Golden, CO.

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Specialties

Biotechnology

Interested Topics

Biotechnology, Analytical development, Formulation development, Monoclonal antibody, Insulin analogs, Cytokines, Therapeutic proteins

State Licenses

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Board Certifications

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Professional Association

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Languages

English

Conference Session Materials

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