Neta Meidav
Zheng Li
- Presentation Title: Case examples of PAT-based modeling on the journey of digital transformation – from Process Development to Manufacturing and Beyond
- Presentation Abstract
Modeling based on process analytical technology plays an important role in the journey of digital transformation at Genentech/Roche. Three case studies will be presented based on recent developments in process development, drug substance, and drug product manufacturing. The first case focuses on the deployment of image analysis in cell line development to achieve faster cell screening. The second case illustrates the development and deployment of an online liquid chromatographic (LC) system to measure the critical process parameters (CPPs) and critical quality attributes (CQAs). The last case was about using Artificial Intelligence to achieve automatic vial inspection for parenteral drug products.
- Short Biography
Zheng Li joined Vacaville Manufacturing facility in 2020 as senior manager and innovation lead of Genentech/Roche to lead the digital science group and digital transformation initiatives. Before that, he was working in pharma development for eleven years in several roles including automation, process development, and digital transformation. As a researcher, Zheng promotes better biological development and manufacturing with AI algorithms. As a leader, Zheng is recognized for influencing the industry and health authorities in the areas of deploying and validating process analytical technology for manufacturing.
Preeya Boppana
Dr. Ecevit Bilgili
Dr. Ecevit Bilgili is a professor, master teacher, and associate chair of the Chemical and Materials Engineering department at NJIT. His Particle Engineering and Pharmaceutical Nanotechnology Lab has been conducting research in designing formulations and processes for high-value-added products like pharmaceuticals with enhanced functionalities.
His research interests center on the development of a fundamental understanding of the mechanisms involved during the formation of drug nanoparticles via top-down and bottom-up approaches, nanocomposite microparticles, and amorphous solid dispersions. Prior to this academic position, Dr. Bilgili worked as Principal Development Engineer within R&D and Pharmaceutical Commercialization Technology Department at Merck & Co., Inc. during 2004–2009.
Dr. Bilgili is a well-recognized member of the Particle Technology Community. He served as an elected Executive Committee Member of the Particle Technology Forum of AIChE. He also served as the Chair & Vice-Chair of AIChE Area3a: Particle Production and Characterization. Dr. Bilgili authored about 100 peer-reviewed journal articles, 5 U.S. patents, and several invention disclosures. He delivered 120+ national/international conference presentations and 30+ invited talks. Dr. Bilgili serves as an Associate Executive Editor of Advanced Powder Technology, an Editor of Pharmaceutics and Powders journals, and an Editorial Advisory Board member of Pharmaceutical Research. He is a recipient of numerous Excellence in Teaching Awards from NJIT and the George Klinzing Best PhD Thesis in Particle Technology Award from the AICHE. In 2022, he was elected as a Fellow of AIChE.
Dragan Djordjevic
Dragan has been at Takeda since March 2020 and is currently leading the modeling group in Cambridge, MA. He has previously worked at Seven Bridges, delivering solutions for genomic and phenotypic analysis at scale, as well as front-end web development at multiple companies after leaving Belgrade with two Master's degrees, in Fine Art and Mechanical Engineering.