Senior Director, Manufacturing Science and Technology
Peter Millili received his Bachelors and Masters degrees in Chemical Engineering from Drexel University, and his Ph.D in Chemical Engineering from the University of Delaware. Previously, he worked at Merck & Co. in Vaccine Manufacturing, supporting technical elements associated with the purification, formulation, and lyophilization of live virus vaccines. Presently, he works at Bristol Myers Squibb, managing a group of scientists and engineers who support the development, technology transfer, and launch of new biologics in the Manufacturing Science and Technology organization. He has been an ISPE member for the past 15 years, and is currently an active member of the process capability sub-team of the PQLI technical team. He has presented at multiple conferences on the topic of formulation design, process development, and technology transfer of large molecules.
Globally, there is an increase in approved advanced therapy medicinal products (ATMPs), with thousands of therapies currently in various stages of pre-clinical and clinical development.
Cell and gene therapy (C>) products represent a significant step forward in patient treatment and often offer unique patient benefits. However, product developers face significant hurdles within the regulatory landscape. The tools laid out in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q12 guideline: “Technical and...