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Late Stage Bioprocessing Digital Week

Optimisation of the AAV Expression Using Dedicated HPLC System

Speaker: Dr Ivana Petrovic Koshmak, Head of Upstream Process Development

Date & Time: November 3, 2021 | 3pm CET / 2pm GMT / 10am EDT

Key points:

Adeno associated virus (AAV) is the leading vector in the field of gene therapy because of its low toxicity, good overall safety profile, and ability to maintain stable expression for long periods of time. It is therefore crucial to develop a robust and high efficiency platform for its manufacturing.

One of the key challenges in manufacturing viral vectors is to increase the 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 realised by process optimisation using at-line HPLC to allow for analysis of the full and empty capsids ratio during the virus expression.

Fast and reliable in HPLC methods to allow for process optimisation USP and DSP, and assessing the purity of the final product using PATfix system will be presented.

Safety vaccines secured by novel Adeno virus vector manufacturing platform

Speaker: Ales Strancar, Managing Director

Date & Time: November 10, 2021 | 11 am EST / 4 pm GMT / 5 pm CET

Key points:

Some side effects of the vaccination might be attributed to the impurities in the vaccines. The vaccines should therefore be as pure as possible. Constant improvement of the impurity detection methods followed by enhancement of the vaccine purity and is therefore necessitated. In this work we present novel adenoviral vectors purification manufacturing process based on monolith chromatography supported by fast and sensitive HPLC analytics. The novel industrial process secures better purity at higher yields. The robustness of the process was verified using different upstream materials. Last but not least, higher capacity of the columns used in this process overcomes the raw material supply bottlenecks.

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