Round table discussion: Successful suspension-based viral vector manufacturing scale-up, from process development to clinics

Denis received his undergraduate degree in Biology from Clark University and his PhD from Worcester Polytechnic Institute in Massachusetts, where he studied stem cell biology and cellular reprogramming. Denis spent two years as a post-doctoral researcher studying cellular microenvironments and 3D tissue engineering of skeletal muscle tissue models. Prior to joining Pall, Denis spent 9 years in the biotech field holding several positions at large pharma and Contract Research Organizations (CROs), supporting upstream and downstream processes for early discovery programs. He joined Pall in 2017 and currently leads the Process Development Services (PDS) team in Westborough MA. Prior to leading the PDS team Denis led the US technical field applications team supporting the adaptation of continuous bioprocessing and bioprocess intensification solutions.

Lenore Giannunzio is a Principal Research Scientist at Andelyn Biosciences working in the MS&T department. She is currently working on scale-up of Andelyn’s bioreactor production and purification platform. Previously, she worked at Nationwide Children’s Hospital in the GMP Production Facility as the Process Development Manager for AAV and Operations Manager for Cell Based Therapies. At NCH, she developed and implemented production and purification processes that are now being used at Andelyn. Lenore has also worked in contract manufacturing and analytical testing at Battelle; in fermentation and dry chemistry testing at GDS Technology (now EKF/StanBio), and in protein purification at Michigan State University and Alma College. Lenore has a BS in biochemistry from Alma College in Alma, Michigan.

Cassie-Marie Peigné, PhD. is the Bioprocess Applications Specialist Team Leader at Polyplus®, a leading provider of upstream process solutions for advanced biologic and Cell and Gene Therapy production from research to commercial grade. Cassie completed her PhD in Immunology at the University of Nantes, followed by a postdoctoral position in Infectious Diseases at the Okinawa Institute of Science and Technology, before joining Polyplus® in 2018.

Timothy P. Cripe, MD, PhD is chief of the Division of Hematology and Oncology at Nationwide Children’s Hospital, a Gordon Teter Endowed Chair in Pediatric Cancer at Nationwide Children’s Hospital and a Professor of Pediatrics at The Ohio State University. Dr. Cripe received his undergraduate degree in Biochemistry from Princeton University and his M.D. and Ph.D. in Genetics from the University of Iowa. He completed his pediatric residency training at the University of Iowa Children’s Hospital and his subspecialty fellowship training in pediatric hematology/oncology from Dana-Farber Cancer Institute/Children’s Hospital, Boston and the University of Colorado/Children’s Hospital, Denver. He was on faculty at the University of Wisconsin-Madison and Cincinnati Children’s Hospital prior to coming to Nationwide Children’s. He has been a principal investigator of a research laboratory studying virotherapy and gene therapy for cancer for the past 27 years, funded by numerous NIH R25, R01, P01, P50 and U54 grants and non-profit foundations. Most recently, he is a co-founder of Vironexis Biotherapeutics, Inc., developing adeno-associated virus gene therapy for cancer.