As in vivo gene therapy applications continue to demonstrate efficacious clinical data, many challenges remain to be addressed. Manufacturing capacity, supply chain logistics, production and purification yields continue to be a focus for improvement to make these therapies accessible to larger patient populations; and at a sustainable cost. One key to improvement is via implementing high quality process design and process parameters to ensure robustness and reproducibility. Process development is a critical part in both upstream and downstream and in recent years, osmolality, a measure of solute concentration, has been shown to be strongly implicated across the entire gene therapy process workflow.
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