Digital data transformation: optimizing CGT processes and accelerating scale-up & tech transfer for manufacturing success

Cell & Gene Therapy Insights 2022; 8(8), 773;

DOI: 10.18609/cgti.2022.116

Published: 8 September 2022
Teodor Leahu

  • Bridging the data gap between R&D and manufacturing with purpose-built software
  • Best practices on using technology to ensure highly complex CGT processes are successfully replicated and controlled
  • Establishing reasonable expectations for data visibility and sharing in sponsor/CMO relationships
  • Identifying the right time to build a digital data strategy and key IT requirements when choosing a software platform

Teodor has 14 years of expertise as a scientist in biotech process development, design, optimization, and validation. His successful track record building and managing technology roadmaps for GMP manufacturing, including software selection, qualification, and implementation, position him as a respected advisor on maximizing operational efficiency to accelerate scale-up, tech transfer, and commercial release. Before joining IDBS, Teo served as Process Development Scientist at Emergent BioSolutions, where he led science and technology for a newly developed orphan disease vaccine. Previously at Merck Healthcare, his roles spanned Bioprocess Development Scientist and Compliance Specialist for Downstream Processing. Teo holds a BS in Biomedical Engineering from Yale University and an MS in Biotechnology and Bioengineering from EPFL (Swiss Federal Institute of Bioengineering).