Current technological trends & advancements in vector purification

Elisa Manzotti speaks to Ying Cai, Nathalie Clement, Chantelle Gaskin, Matt Roach & Ashish Saksule

Ying Cai is the Sr. Director of Process Development at Ultragenyx Pharmaceutical. She heads AAV downstream process development and formulation development functions, also a CMC lead of AAV clinical programs. Prior to joining Ultragenyx, Ying worked at Sanofi, Biogen, Merck, and a few CDMOs. Ying has over 20 years’ experience in the development, validation, manufacturing and commercialization of different modalities including AAV, plasmid DNA, oligonucleotides, antibodies, antibody conjugates, and fusion proteins. Ying holds a Ph.D. in Chemical Engineering from the University of Arkansas at Fayetteville and a B.S. in Biochemical Engineering from Zhejiang University in China.

Nathalie Clement has more than 25 years of experience in the field of Gene Therapy, with a strong expertise in viral vectors, specifically adeno-associated vectors, in the academic and industry settings. Her research focus has strongly been focused on optimizing processes to support large-scale production of high quality rAAV stocks and their implementation into the GMP settings. During her thesis work at the University Libre of Brussels, Belgium, she developed new recombinant viruses derived from the parvovirus Minute Virus of Mice (MVM) for cancer-selective gene therapy treatments. She then joined Dr. Michael Linden’s laboratory at Mount Sinai School of Medicine, New York, where she developed novel recombinant AAV vectors and directed the AAV Vector Core. She next joined the Powell Gene Therapy Center in 2008 as the Associate Director to supervise AAV production and testing at research, preclinical and clinical grades. She led the Process and Development Group and the Quality Control group responsible for the production and release of all AAV pre-clinical and clinical lots. During her time at UF she oversaw manufacturing, release and stability campaigns of more than 7 AAV INDs from start to finish, including CMC preparations and interactions with FDA. More recently, she spent several months at Resilience, Alachua, Florida, as the Director of Process and Development of the Viral Vaccines and Gene Therapy franchises. IN that role she oversaw viral vaccine and AAV production scales up to 200L in suspension format and in the icellis 500 platform for adherent platforms of a variety of viruses and AAV vectors. Currently Nathalie is taking a break before starting a new adventure in 2022.

Chantelle Gaskin is a Field Applications Scientist, specializing in protein and viral vector purification and downstream process development. She held leadership positions at Applied Genetic Technology Corporation and Brammer Bio, prior to joining the Thermo Fisher Scientific Bioproduction Division in 2020. With over 10 years of experience in gene therapy, Chantelle has accumulated comprehensive knowledge of standard industry practices and regulatory standards, applying this knowledge to advance development of therapies for a variety of indications including ocular, CNS and systemic disease.Chantelle holds a Master’s degree in Chemistry from University of Florida and a Bachelor’s in Chemistry from Smith College.

Matt Roach leads the AAV Process Development group at Precision BioSciences, which is focused on designing and implementing new strategies for the production and purification of adeno-associated virus. Matt completed his Bachelor’s degree in Biological Sciences at North Carolina State University and his Master’s degree in Microbiology and Cell Science at the University of Florida. Prior to Precision, Matt spent time at Pfizer working on the purification of AAV and the Biomanufacturing Training and Education Center training industry professionals on downstream bioprocessing operations.

Ashish Saksule is the Cell and Gene Therapy process development lead and technical expert on bioprocessing platforms for viral vectors (Lentivirus and Adeno-associated virus vector) and non-viral vectors with more than 7 years of experience. Ashish has graduate degree in Chemical Engineering from Michigan Tech University, and Biotechnology graduate degree from Harvard University. His experience spans research & drug development, clinical stage and CRO/CMO settings. Ashish is currently working at Takeda within Global Gene Therapy and have previously worked at MilliporeSigma and Miltenyi Biotec.

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