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Whilst cell and gene therapies can potentially revolutionize disease treatment, challenges remain in order to make these novel drugs accessible to larger patient populations. For now, downstream recoveries are as low as 5-30% for viral vector production, depending on the process. Manufacturing capacity, production yields, and supply chain logistics continue to be an area of focus for improvements. The key to improvement and success is through implementing high quality process design and process parameters to ensure robustness and reproducibility. An important question for scientists in the area is, ”What tools and checks can be implemented to ensure consistent product and process control”? Osmolality, a measure of solute concentration, has long been considered a critical measurement in Biopharma describing how much of a solute is present in a given solution. More recently, it has been shown to be strongly implicated across the entire gene therapy process workflow. It’s clear for example that in upstream vector production, osmolality is a factor affecting yield, quality and process efficiency. Also, in the downstream workflow it has been shown to reduce the potential for aggregation during UF/DF filtration process. Within Analytical Development and QC it has been used practically for final product formulation and QC.
In this workshop, we’ll hear the latest from Kendal Studd of Advanced Instruments about the range of ways in which osmolality can improve efficiency and recovery within the CGT manufacturing process both for AAVs and Lentiviruses.
Dr Adrien Soula of the Cell and Gene Therapy Catapult will present brand new data from a study, completed in June 2021, that showed a significant increase in yield and quality of an AAV resulting from a timed osmolality shift. Additionally, his data will show how the shift had a profound effect on the relative extracellular vs intracellular vector yield with exciting implications.
Lucia Marani from Oxford Biomedica’s Analytical Development team will discuss their recent and innovative use of osmolality as a product stability indicator, further augmenting its commonly adopted use for formulation and QC applications.
If you’re a lead scientist working in viral vector manufacturing, you shouldn’t miss this important workshop