Real-World Insights on Cell and Gene Therapy Development: Navigating the Complexities of Critical Quality Attributes

Srujan Gandham is the Associate Director of Analytical Development at Aera Therapeutics, where he leads analytical method development efforts focused on the characterization and quantitation of novel delivery systems (PNPs). Before joining Aera, Srujan was at Moderna, where he developed analytical methods for the characterization and impurity profiling of drug substances(mRNA) and drug product (LNP/mRNA). He played a key role in several of Moderna’s BLA and IND filings for various mRNA clinical programs, including mRNA-1273 (Moderna’s first COVID-19 vaccine). Srujan holds a PhD in Pharmaceutical Systems and Drug Delivery Systems from Northeastern University with research centered on understanding the contents of extracellular vesicles in mouse models of ovarian cancer.

Andrew leads the viral vector process development group at Regeneron Pharmaceuticals, focused on developing bioprocesses for Adeno-associated virus (AAV) based viral vectors to cure diseases such as Hemophilia B, congenital hearing loss, and Pompe disease. Andrew has worked at Regeneron since 2009. Prior to moving to gene therapy Andrew co-led the purification development group for protein therapeutics, working on Fc-fusion, monoclonal antibody, and bispecific processes. He has worked on the process development for the FDA-approved drugs Dupixent®, Libtayo®, Inmazeb™, Kevzara®, Evkeeza™ and Praluent®, and helped develop the bispecific antibody platform at Regeneron. Andrew received his doctorate in biochemical engineering from University College London and his undergraduate masters in biochemistry from the University of Oxford.

Dr. Mansoor Amiji is currently the University Distinguished Professor, Professor of Pharmaceutical Sciences, and Professor of Chemical Engineering at Northeastern University in Boston, MA. Dr. Amiji received his BS degree in pharmacy from Northeastern University in 1988 and a PhD in pharmaceutical sciences from Purdue University in 1992. Dr. Amiji’s teaches both undergraduate and graduate students at Northeastern University. His research is focused on development of biocompatible materials from natural and synthetic polymers, target-specific drug and gene delivery systems for cancer and infectious diseases, and nanotechnology applications for medical diagnosis, imaging, and therapy. Dr. Amiji has edited twelve books and has published over 60 books chapters and over 400 peer-reviewed articles. He is a Highly Cited Researcher (top 1%) in Pharmacology and Toxicology and has a Google H index of 105. Dr. Amiji has received a number of honors and awards including the Nano Science and Technology Institute’s Award for Outstanding Contributions towards the Advancement of Nanotechnology, Microtechnology, and Biotechnology, American Association of Pharmaceutical Scientists (AAPS) Meritorious Manuscript Award, Controlled Release Society’s (CRS) Nagai Award, and he is a Elected Fellow of the American Institute of Medical and Biological Engineering (AIMBE), AAPS, and CRS.

Michelle is the Head of Cell and Gene Therapy at Revvity. In this role, Michelle steers the strategic direction and influences how Revvity showcases its diverse array of CGT capabilities, across products, contracted services and technology licensing, to facilitate the advancement and launch of innovative cell and gene therapies. Michelle has a PhD in mycology and a Graduate Diploma in Science and Technology Commercialization from the University of Adelaide. She was previously manager of Revvity’s base editing business and our next generation sequencing product portfolio.