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Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

Expert Roundtable

AAV vector process development: achieving high purity and high yield – experiences from the frontline

Meisam Bakhshayeshi, Michael Mercaldi, Matthias Hebben & Orjana Terovo

Earlier this year, four of the leading vector bioprocess experts working in gene therapy today assembled to debate key challenges relating to the scalability and robustness of current production systems.

Dr Meisam Bakhshayeshi (Head of Downstream Process Development for Gene Therapy, Biogen), Dr Michael Mercaldi (Director of Purification Process Development, Homology Medicines), Dr Matthias Hebben (VP Technology Development, LogicBio Therapeutics) and Orjana Terova (Senior Product Manager for Purification Products, Thermo Fisher Scientific) were asked to share their insights relating to critical manufacturing bottlenecks currently obstructing gene therapy’s path to commercial validation and success.

Low cell culture titers, poor scalability of both upstream and downstream steps, the frequent lack of manufacturability of vector platforms, cost control issues…AAV bioprocessing is certainly at something of a crossroads, struggling to improve productivity even as demand spirals. Don’t miss this unique opportunity to hear directly from those tasked with delivering the strategic and technological solutions and inform your own viral vector scale-up plans.

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MEISAM BAKHSHAYESHI
Head of Downstream Process Development for Gene Therapy, Biogen
Meisam is Head of the gene therapy downstream process development at Biogen. In this role, Meisam oversees development of purification processes to support Biogen’s AAV gene therapy portfolio. Meisam has 8 years of experience in developing downstream processes for protein biologics and viral vectors at different stages of development. Meisam received a PhD in Chemical Engineering from The Pennsylvania State university.

MICHAEL MERCALDI
Director of Purification Process Development at Homology Medicines
Michael is the Director of Purification Process Development at Homology Medicines and is responsible for leading the development of Homology’s purification manufacturing processes for their gene therapy and gene editing programs. He has worked purification process development throughout his career at MedImmune/AstraZeneca, Merrimack Pharmaceuticals and Codiak Biosciences before joining Homology. He holds a BS in Chemical Engineering from the Rensselaer Polytechnic Institute and a PhD in Biochemical Engineering from Tufts University.

MATTHIAS HEBBEN
VP Technology Development, LogicBio Therapeutics
Matthias has served as VP Technology Development since February 2019.Before that, he served as Director of AAV Technology Development and head of bioprocess development at Genethon for 6 years, where he managed the design and scale up of manufacturing processes for AAV and LV vectors. Prior to his role at Genethon, Matthias was Director of the Virology Unit at Vivalis for 4 years. Before that, he occupied several roles in the animal health industry at Intervet Schering Plough and Virbac between 1999 and 2008. Matthias has a PhD in molecular biology from the University of Nice Sophia Antipolis (France) and a bioprocess engineer degree from the University of Strasbourg (France).

ORJANA TEROVA
Senior Product Manager for Purification products at Thermo Fisher Scientific
Orjana is Senior Product Manager for Purification products within the Bioproduction Division at Thermo Fisher Scientific. Orjana has a M.S. in Chemistry from University of New Hampshire (in 2008). She also has 11 years of industrial experience at Thermo Fisher Scientific. Her expertise includes a strong technical background in small molecule and bead chemistries, new product development and commercialization. In her current role Orjana is responsible for managing globally the POROS Chromatography product line, including life cycle product management, implementing programs to drive business growth strategy and support of the global sales organization.

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