Christina Vessely

Responsibilities include support of clients at all stages of development from early R&D through commercialization with tasks including laboratory and regulatory agency interaction. Product types include peptides, cytokines, insulin analogs and other therapeutic proteins, monoclonal antibodies, vaccines including virus-like particles and other adjuvants/methods for enhancement of immunity. representative projects have included the following. • Development, qualification and validation of analytical methods for in-process testing, lot release, stability studies, and comparability assessment. • Application of biophysical and biochemical techniques for extended characterization to demonstrate comparability and biosimilarity. Techniques include various types of spectroscopy for evaluation of primary, secondary, tertiary and quaternary structure, differential scanning calorimetry and other methods for evaluating thermal properties of proteins, and evaluation of subvisible particles • Development and characterization of critical reagents including product specific reference standards and assay specific reagents. Development of strategies for demonstration of continuity of the standards across the product life span • CMC strategy and execution including strategies for the evolution of analytical methods across a development program, the development of storylines for sections of IND/IMPDs, BLA/MAAs, or other regulatory submissions including pre-meeting packages or briefing books. Provide support for preparation of pre-approval inspections (PAI) and other agency inspections. • Formulation strategy and development including the design of preliminary and later stage formulation screening studies, the application of biophysical techniques to evaluate formulation stability for short term studies, the evaluation of stability profiles for lead candidate formulations in longer term studies, and the evaluation of container/closure systems for drug substance and drug product.

Leading a team of 7 regulatory professionals, technical experts, and documentation specialists in IND/BLA enabling activities for clients. Work includes writing/editing of CMC sections for regulatory filings, including analytical and process/formulation development sections for both drug substance and drug product. -Providing support for the development, characterization, and approval of new primary and secondary reference standards. -Providing support for the development of strategy, protocol writing, and report writing for various stability studies -Providing support for the development of strategy and reporting for comparability stuides -Strategy and development of specifications and justification of specifications in support of regulatory filings -Providing support in preparation for and during regulatory inspections (PAI, etc) -Providing support for other BLA/PAI enabling activities as requested by the clients

Technical lead for the development of stable formulations and analytical methods for assessment of product quality for therapeutic protein products. Responsibilities include leading a team through all stages of formulation development, including pre-formulation, long term stability assessment, and late stage formulation trouble shooting. Expertise in the areas of biophysical characterization, including spectroscopic, thermal, and particle counting/characterization techniques. Responsibilities also include the development, qualification, validation and transfer of analytical methods. From August 2012 – May 2014, duties additionally included work on a high priority project, Keytruda, focused initially on bringing analytical and raw material practices for an EU site within the Merck network from clinical to commercial stage. Specific duties for this position have included: • Member of core team for CMC for multiple filings for Keytruda including BLA. Participation in meetings with FDA via teleconference. • Technical oversight of GMP stability programs, OOS and other laboratory investigations. Stability strategy design and review • Participation in specification setting at various stages of development • Planning and execution of formulation and fill/finish operations for drug product used in preclinical studies utilizing aseptic technique • Project management for fill/finish operations for clinical studies • Testing and selection of appropriate container/closure systems for DS and DP • Technical lead for the development of reference standards for multiple therapeutic protein projects • Design and execute chemical and biophysical characterization studies to show process to process comparability • Travel to domestic and international Merck sites to provide support to therapeutic protein product development. • Close collaboration with process, technical operations, and other teams within Merck. • Direct line management of up to seven full time staff members

Responsible for the development of a high concentration, lyophilized formulation for a novel therapeutic protein for the treatment of Myotonic Muscular Distrophy. The project focused on development of both vial and dual-chamber cartridge configurations. Specific activities have included: • Testing and selection of appropriate container/closure systems, and coordination of fill finish activities performed at contract manufacturing sites. • Development of analytical methods specific to the determination of purity and potency for both active ingredients and inactive formulation excipients. • Extensive participation in method qualification studies, including the writing, reviewing and implementation of protocols and reports. • Interaction with both internal regulatory affairs department and the FDA to determine requirements for filing and obtaining approval on new drug formulations. • Development and characterization of a master reference standard. • Participation in the writing of the CMC sections of IND, IMPD, and other regulatory filings. • Performance of thorough biophysical characterization studies to show comparability between formulations and processes. Studies include spectroscopic, thermal, and particle characterization methods. • Management of up to four full time employees

 Ph.D, Pharmaceutical Sciences with a specialization in the field of formulation development for biotechnology products. Advisor: Dr. John Carpenter. Committee Members: Theodore Randolph, Daniel Schwartz, David Bain, Latoya Jones  Research: Adsorption of proteins at interfaces. Project work includes investigation of adsorption to solid particulate matter for drug delivery application, investigation of vaccine-adjuvant interactions, and investigation of the interfacial rheology of proteins at the air-water interface. Projects also incorporate general principles on stabilization of protein pharmaceuticals, and the development of analytical methods for the characterization of protein drug products. Analytical methods include SEC HPLC, RP-HPLC, light scattering, 2DUV, CD, Fluorescence, FTIR, DSC, Gel Electrophoresis, and some exposure to peptide mapping Mass Spectrometry.  Began program while working full time at FeRx and transitioned to a full time student from February 2003 to July 2005.

Describe your position

Describe your position

 Ph.D, Pharmaceutical Sciences with a specialization in the field of formulation development for biotechnology products. Thesis advisor was Dr. John Carpenter  Research: Adsorption of proteins at interfaces. Project work includes investigation of adsorption to solid particulate matter for drug delivery application, investigation of vaccine-adjuvant interactions, and investigation of the interfacial rheology of proteins at the air-water interface. Projects also incorporate general principles on stabilization of protein pharmaceuticals, and the development of analytical methods for the characterization of protein drug products. Analytical methods include SEC HPLC, RP-HPLC, light scattering, 2DUV, CD, Fluorescence, FTIR, DSC, Gel Electrophoresis, and some exposure to peptide mapping Mass Spectrometry.  Began program while working full time at FeRx and transitioned to a full time student from February 2003 to July 2005.