Expert Details

Expert in Bioprocess Development

Expert ID: 731283 Massachusetts, USA

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Expert specializes in the development and selection of recombinant protein expression platforms, translating discovery candidates into development programs and the generation of preclinical material. She has successfully built infrastructure, incorporated process improvements and identified innovative approaches for development. She effectively uses collaboration and clear communication to meet program objectives.

Previously, she held a position as Associate Director, Bioprocess Development at Momenta Pharmaceuticals, where she was responsible for building a team and laboratory space for the development of biosimilars. She is named as an inventor on 11 patents/patent applications and over 16 scientific publications. She is a member of the steering committee for the Mass Biotech Council Upstream Forum.

Primary Services include:
• Selection of appropriate expression technologies
• Cell line development and characterization
• Cell banking and testing
• Small scale and bioreactor cell culture process development and troubleshooting
• Media and feed selection and optimization
• Selection of analytical methods to support development
• Technical due diligence and management of CRO/CMOs
• Development of program plans and project oversight



She provided review and guidance for client workplans
She identified options for material generation to support preclinical studies and approaches for the development of stable cell linesShe provided critical review of a $700K CMO proposal and input on cell bank testing requirements
She prepared an expert statement in connection with a patent disputeShe prepared an RFP for the identification of an appropriate CMO for the production of a cell therapy product and aided the client in the selection of the CMO. Following that she provided oversight for the activities pertaining to the transfer of a clinical process, the development of a new process, and cell banking.

Expert may consult nationally and internationally, and is also local to the following cities: Boston, Massachusetts - Worcester, Massachusetts - Springfield, Massachusetts - Lowell, Massachusetts - Cambridge, Massachusetts - Brockton, Massachusetts - New Bedford, Massachusetts - Hartford, Connecticut - Manchester, New Hampshire - Providence, Rhode Island

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Education

Year Degree Subject Institution
Year: 1993 Degree: PhD Subject: Molecular Biology Institution: Harvard University
Year: 1981 Degree: Bsc Subject: Biology Institution: Rensselaer Polytechnic Institute

Work History

Years Employer Title Department Responsibilities
Years: 2013 to Present Employer: Undisclosed Title: Principal and Owner Department: Responsibilities:
Years: 2006 to 2013 Employer: Momenta Pharmaceuticals Title: Associate Director Department: Biologics Process Development Responsibilities: Built and directed a process development group for follow-on biologics using proprietary technologies to meet product quality targets. Oversaw multiple CMO/CROs for development activities.
Years: 2008 to 2011 Employer: Millipore Corporation Title: Manager Department: Pre-Development Responsibilities: Led a team responsible for the development and evaluation of novel mammalian expression technologies.
Years: 1996 to 2006 Employer: Biogen Idec Title: Principal Scientist Department: Process Development Responsibilities: Responsible for more than seven clinical or commercial cell line development programs and the transition of programs from research to development.
Years: 1993 to 1996 Employer: Ares Advanced Technologies Title: Principal Investigator Department: Responsibilities: Development of novel expression technologies and generation of recombinant material in baculovirus

Career Accomplishments

Associations / Societies
American Chemical Society, Parental Drug Assoc., Mass Biotech Council Upstream Forum Steering Committee
Publications and Patents Summary
She has 17 journal articles, 1 book chapter, and 11 patents

Additional Experience

Training / Seminars
Technical training in early stage bioprocess development
Vendor Selection
Expertise in the assessment of CRO/CMOs in bioprocess services.
Marketing Experience
Expertise in the development and assessment of bioprocess technologies. Specialized in the areas of upstream development such as cell line, vectors, media, feeds, transfection, and bioreactor components.
Other Relevant Experience
• Selection of appropriate expression technologies
• Cell line development and characterization
• Cell banking and testing
• Small scale and bioreactor cell culture process development and troubleshooting
• Media and feed selection and optimization
• Selection of analytical methods to support development
• Technical due diligence and management of CRO/CMOs
• Development of program plans and project oversight

Fields of Expertise

bioprocessing, biotechnology assessment, contract service management, culture medium, mammalian cell culture, monoclonal antibody production, protein characterization, metabolomics, Chemistry, Manufacturing and Controls, patent application, analytical method optimization, glycosylation, proteomics, advanced glycosylation end products, isotype, epitope, pharmaceutical technology, microplate, epitope mapping, SDS-PAGE, ferritin, Current Good Manufacturing Practice, bioprocess engineering, cell bank, pharmaceutical product development, tissue culture medium, pharmaceutical manufacturing facility auditing, cell death, protein isolation, cell culture incubator, immortalized biological cell, protein concentration process, electroporation, glycoprotein analysis, applied biotechnology, protein analysis, mitogen, incubator, protein biology, protein biochemistry, DNA technology, metabolic engineering, fermentation technology, recombinant protein, drug development, technology evaluation, quality assurance, cellular regulation, bioreactor design, bioprocess, heat-shock protein, genetically engineered material, fermentation, Food and Drug Administration regulation, protein chemistry, protein engineering, recombinant DNA technology, recombinant DNA, bioengineering, protein, enzyme, tissue culture, protein synthesis, protein purification, new drug application, monoclonal antibody, molecular biology, immunoglobulin, glycoprotein, genetics, genetic engineering, gene expression, enzyme production, chromatography, cell physiology, cell culture, biotechnology, bioreactor, biochemistry, bacterial culture

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