Sharing personal experience on the development of cell therapy technology, quality & analytics since the 1990s & the application of ‘phase appropriate GMPs’ to cell therapy development

Abstract

David McCall, Commissioning Editor, BioInsights, spoke to Amnon Eylath, VP Head of Global Quality, Minovia TherapeuticsAmnon Eylath is a seasoned Quality Leader, experienced in the life cycle of Small molecule, and Biotech drug development, including R&D through nonclinical and GLP Tox studies, clinical trials, process and method development, manufacturing, validation, regulatory submissions for clinical trials and US/EU product approvals, to global distribution of commercial products. Direct experience with Therapeutic Monoclonal Antibodies, Cell and Gene Therapy. Led/supported cross-functional Continuous Improvement & Gap-Remediation initiatives at multiple companies. Implemented multiple electronic QMS systems at small and large companies. Initiated Amgen’s Lean-Six Sigma program and Black Belt. Presented at PDA and ISPE events on multiple subjects, including Cost-Effective Validation, Sanitization using Chlorine Dioxide Gas, and more. Active speaker on Qualistery – GXP educational web-seminars. Member and volunteer at the PDA since 1996, leading the TR-56 technical report task force on Phase Appropriate Application of Quality Systems and GMP, co-author on TR-65 Technology Transfer (version 1.0). Past President of the New England Chapter of the PDA, supporting the New England BioPharma community and the Middlesex community College Biotechnology certificate/degree program and NEPDA scholarship awards. Member of the MSCC Biotechnology Program Advisory Board and founding member of the Northeastern University Biotechnology Program Advisory Board.