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Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

AAV downstream processing for industrial scale production – moving towards commercial manufacturing

Thermo next gen manufacturing gene therapieSponsored by:

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Major progress has been made in the area of gene therapy and due to improved safety and efficacy, the Adeno-Associated Virus (AAV) has emerged as an important vector for the development of gene therapies. With a growing pipeline of clinical trials, it is evident that scalable viral vector manufacturing technologies are needed by this rapidly growing industry. Next to scalability, product safety and purity needs to be demonstrated before regulatory approval is attained.

In this presentation we discuss the benefits of implementing affinity chromatography in the downstream purification of viral vectors. The utilization of POROS™ CaptureSelect™ AAV affinity resins results in a significant improvement to the downstream process of AAV. By reducing the number of purification steps, maximizing productivity, offering scalability and process consistency, these resins can be used for clinical and commercial manufacturing.

In conjunction, the importance of understanding regulatory requirements such as process and product impurity clearance and viral clearance are discussed and results of a viral clearance study are shown. This study demonstrates that the POROS™ CaptureSelect™ AAVX affinity resin could serve as an effective viral clearance removal step in the downstream manufacturing of these vectors.

Attendees will:



Headshot Mikhail Goldfarb

Mikhail Goldfarb, Principal Scientist, Downstream Process Development, REGENXBIO

Mikhail Goldfarb joined REGENXBIO in March of 2019 as the Principal Scientist within the Downstream Process Development group. In his current role he is responsible for development, optimization, characterization, scale-up, technical transfer and validation of cGMP-compliant manufacturing processes for recombinant viral vectors. Prior to joining REGENXBIO, Mikhail has worked at Novavax, GlaxoSmithKline (Human Genome Sciences), Janssen Biotech (Centocor), WuXi AppTec and Lonza Biopharmaceuticals (Cambrex Bio Science). He has over 20 years of experience in early and late stage downstream process development. Mikhail holds a Masters degree in Biotechnology from Johns Hopkins University and a Bachelors degree in Chemical Engineering from Carnegie Mellon University.



Orjana Terova

Orjana Terova, Senior Product Manager, Bioproduction Division, Thermo Fisher Scientific

Orjana Terova is a 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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