David Wolf - Sudbury MA, US Claire McGrath - West Boylston MA, US Willem Kuhtreiber - Shrewsbury MA, US Jeanine Lorusso - Sterling MA, US Angela Pollard - Westminster MA, US
International Classification:
A61K009/00 A61K009/48 A61K009/50
US Classification:
424/400000, 424/451000, 424/093700
Abstract:
A method of determining a suitable microreactor for a predetermined host including identifying a suitable microreactor diameter, optionally identifying a minimum second matrix thickness, and optionally identifying a microreactor having a centrally located microcapsule. A microreactor having a diameter such that, when implanted in a higher order mammal, the microreactor exhibits no greater than 25% fibrosis for at least 14 days after implantation. A microreactor that includes a semipermeable membrane capable of eliciting a fibrotic response from a higher order mammal, and a second matrix surrounding the semipermeable membrane, the second matrix being of a thickness sufficient to prevent nucleation of fibrosis by the semipermeable membrane when the microreactor is implanted in a higher order mammal for at least 14 days.
Repligen Corporation
Senior Director of Quality
Rcri, Inc. (Regulatory & Clinical Research Institute, Inc.) Jan 2016 - Mar 2016
Independent Consultant
Sekisui Diagnostics, Llc Mar 2013 - Nov 2015
Corporate Quality Compliance Director
Sekisui Diagnostics, Llc Feb 2010 - Feb 2013
Quality Assurance Manager
Synta Pharmaceuticals Mar 2008 - Feb 2010
Senior Quality Assurance Manager
Education:
Dale Carnegie Management School 2003 - 2003
Syracuse University 1977 - 1981
Bachelors, Bachelor of Science, Biology
Skills:
Validation Gmp Fda Quality System Change Control Quality Assurance 21 Cfr Capa Quality Auditing Medical Devices Quality Control Document Management Life Sciences Biotechnology Sop Iso Standards V&V Pharmaceutical Industry U.s. Food and Drug Administration Good Laboratory Practice Corrective and Preventive Action Standard Operating Procedure Elisa Iso Clinical Trials Glp Iso 13485 Management Iso 14971 Lifesciences Cell Culture Assay Development Virology Sharepoint Laboratory Software Documentation Cgmp Root Cause Analysis Risk Management Verification and Validation
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