Overview of Downstream Process of AAV Purification Using Monoliths and Rapid Evaluation of AAV Empty-Full Ratio with the PATfix™ HPLC System

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Event Overview:

BIA Separations, now a Sartorius company, offers already for more than 20 years, the chromatography tools for large biologics. Monolith ready-to use columns, available from analytical scale to industrial scale, are top-notch technology for rapid chromatography, reliable and efficient downstream processes and analytics. Structure of monolith offers a convective mass transport, no diffusion, resulting in high capacities, flow independent resolution and overall rapid process. Downstream process of Adeno associated virus is one of the key platform solutions that company offers to the market.

One of the key challenges in manufacturing of AAV’s is to increase the titer and ratio between empty and full capsids. The most efficient way is to design the USP to result in less than 10% of empty capsids. This can be realized by process optimization using at-line HPLC to allow for analysis of the full and empty capsids ratio during the virus expression along with monitoring other process and product related impurities.

Fast and efficient HPLC methods using PATfix™ system, allow process optimization in both USP and DSP by assessing the purity from the in-process sample up to the final product.

Key Learning Objectives:

• Rapid downstream process of AAV using monoliths, with emphasis on PATfix HPLC analytical tools
• Orthogonal analytics are paramount for AAV characterization
• Integration using PATfix enables fast evaluation of empty-full ratio

Who Should Attend:

• Research/Development
• Analytical Methods Development
• Production/Manufacturing
• Process Development
• Senior Analyst
• Scientist

Speakers

Rok Žigon
Project Manager; Process Development Dept.
BIA Separations, now a Sartorius company

Rok is a Project Manager in Process development department for Viruses (viral vectors and vaccines) at BIA Separations, now a Sartorius company. He has 6 years’ experience in the field of downstream bioprocess development, leading gene therapy projects for clients, resulting in processes for clinical phase I, II, III and market supply. He acquired skills in AAV purification using monolithic technology through all production stages from Process Development, Technology Transfer and Manufacturing. He holds a Master’s degree in molecular biology from the University of Ljubljana.

Blaž Goričar
Project Manager; Process Analytical Technology Dept.
BIA Separations, now a Sartorius company

Blaž Goričar holds a Master’s degree in Chemical Engineering from University of Maribor. He joined BIA Separations, now a Sartorius company, in 2016 as a Scientist for analytical method development, focusing mainly on HPLC AAV analytical applications. He is currently the Project Manager in the department for Process Analytical Technology, responsible for PATfixTM hardware and software products.

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