Expert Details
Bioprocess Development
ID: 731283
Massachusetts, USA
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.
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 |
|---|---|---|---|
| Years: 2013 to Present | Employer: Undisclosed | Title: Principal and Owner | Department: |
Responsibilities:Available upon request. |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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 |
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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