Process in the product: a new analytical tool for AAV production optimization and monitoring

Chromatographic analysis of complex AAV presents challenges due to the presence of various impurities, including proteins, DNA, and other matrix species that may coelute with target molecule. In cases where 1D chromatography is insufficient for satisfactory separation, more efficient analytical tools are required.

This webinar will explore the determination of percentage of full capsids in complex samples, including lysed harvests and spent media, with rapid analysis (results provided within 25 mins/sample) and baseline separation of empty and full capsids.

The key challenges of AAV manufacturing will be explored, including the screening of raw materials such as helper plasmids and the optimization of transfection conditions through Design of Experiments (DoE) based on downstream process requirements. Additionally, we will discuss how this analytical tool, alongside digital PCR (dPCR), helped narrow the harvesting time window, reducing accumulation of empty capsids. Participants will gain insights into how the novel analytics can be integrated into their workflows to enhance efficiency and product quality.

Attend this webinar to:

• Gain insights into how the at-line analytics provides precise and reliable data that can inform critical decisions in bioprocessing, leading to more effective and efficient production strategies.
• Explore practical applications of a new AAV analytical platform and its role in optimizing upstream processes through DoE.
• Discover the practical application of the at-line analytical monitoring in bioreactor runs in the context of AAV8 production in HEK suspension cells, and how it can be implemented into existing processes to achieve better results.
• Learn about the scale-up process from shake flasks to 10L vessels and how to determine the optimal harvesting time window to maximize yield and minimize the accumulation of empty capsids.

Blaž Bakalar

Product Manager PATfix® Platformat Sartorius BIA Separations

Blaz completed his BSc in Biochemistry at the University of Ljubljana, Slovenia, with the program having a heavy focus on laboratory methods widely used in the pharmaceutical industry. He obtained his PhD at NTU Singapore, with a focus on nucleic acid biophysics. In 2020 he joined Sartorius BIA Separations as the PATfix product manager. The PATfix analytical platform combines hardware, software and BIA analytical know-how into a single platform package, making his previous experience a valuable contributor in steering the product towards success.

Ivana Petrović Koshmak

Head of Upstream Process Development at Sartorius BIA Separations

Ivana Petrović Koshmak is head of upstream process development at Sartorius BIA Separations in Slovenia, leading a group that optimizes the production of AAV, adenovirus, exosomes, and other vectors. Her team supports internal research and development, as well as customer projects, by developing and applying cell-based assays. The team also supports qPCR, dPCR, and ddPCR analytics, while striving to apply orthogonal methodologies whenever possible.

Ivana is a molecular biologist with a background in gene therapy, previously working at the International Centre for Genetic Engineering and Biotechnology (ICGEB), located in Trieste, Italy. She holds a master’s degree in applied genetics from the University of Belgrade, Serbia, and gained her doctoral degree in biomedical science and biotechnology from the University of Ferrara, Italy.

in 25

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SPEAKERS

Blaž Bakalar

Product Manager PATfix® Platformat Sartorius BIA Separations

Ivana Petrović Koshmak

Head of Upstream Process Development at Sartorius BIA Separations

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