Bio

Carlos E. Ibanez, PhD, is a seasoned leader with 27+ years of Manufacturing Science And Technology (MSAT) operations experience at several viral gene and cell therapy companies from start-up through Phase III PPQ validation. Specialty: Bringing value to companies developing disruptive, lifesaving gene therapy products by combining know how and understanding of the molecular biology of viral vector systems to manufacturing processes to rapidly develop biological products through the use of QbD design principles, strategic regulatory and budget planning, to deliver innovative and cost effective scalable manufacturing through a network of CMOs and/or in-house GMP manufacturing. Multiple issued manufacturing related patents and demonstrated success in the development of stable viral vector producing cell lines, adaptation of adherent cell lines to serum free suspension cultures and the development of automated perfusion fed single-use bioreactor systems to commercial launch ready scales. Experiences include: (1) Continuous manufacturing through effective downstream processing, formulation development, as well as effective lot release testing strategies in concordance with extensive product characterization and comparability testing; (2) Building and leading teams committed to excellence and continuous process improvements; and (3) in person CMC interactions with FDA as part of Breakthrough Therapy Designation (BTD) and EMA as part of PRIority MEdicines (PRIME) designation for promising medicines that target unmet medical needs. Doctorate in Molecular Pathology from the University of California, San Diego, and Post-Doctoral fellow at the Research Institute at Scripps Clinic specializing in the use of retroviral and lentiviral vectors.