From process development to manufacturing: how to successfully optimize and scale up the AAV enrichment step on novel CIMmultus QA HR line

Adeno-associated viruses (AAV) have emerged as leading vectors for gene therapy applications due to their low pathogenicity and ability to mediate long-term gene expression in a wide range of tissues. In each AAV downstream process, one of the key steps (and often a bottleneck) is enrichment of full capsids. Along with scalability and capsid separation challenges, one should account for sample heterogeneity and assess which analytics are adequate to distinguish between AAV sub-populations and deliver only the potent AAV product.

To address these needs, Sartorius BIA Separations developed new CIMmultus HR (High Reproducibility) line columns with better resolution and narrower acceptance criteria. These columns allow for batch-to-batch and scale-to-scale reproducibility within just 3% of the AAV8 empty capsid iso-conductivity elution. Such columns allow for step gradient elution using the same buffer strength at any scale. Two order of magnitude removal of empty capsids should be possible.

A complete enrichment process design on AAV8 case study will be presented., starting from initial screening of conditions using 96-well plate or small monolithic columns, followed by the determination of column capacity, considerations for formation of step gradient, and finally a successful scale-up.

Join us in this webinar to learn about:

• Chromatographic purification of AAV
• Development of the enrichment step
• Improving resolution and reproducibility with the CIMmultus HR line
• Successful scale up

Rok Žigon

Head of Product-Application Area (AAV/Adeno), Process Development, Viruses at Sartorius BIA Separations

Rok is a Head of Product-Application Area (for AAV and Adeno) in Process development department for viral vectors and vaccines at Sartorius BIA Separations. 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.

Maja Leskovec

Head of Process Development, Viruses at Sartorius BIA Separations

Maja is heading Process development Viruses at Sartorius BIA Separations. She has more 10 years’ experience in the field of downstream development, working in laboratory as well as leading development projects for clients, resulting in processes for pre-clinical and clinical applications. She co-developed various DSP processes, including AAV for AveXis/Novartis. One of the key focus of her group is holistic view on the viral production, combining knowledge from upstream, downstream and analytics. 

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SPEAKERS

Rok Žigon

Head of Product-Application Area (AAV/Adeno), Process Development, Viruses at Sartorius BIA Separations

Maja Leskovec

Head of Process Development, Viruses at Sartorius BIA Separations

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