Osmolality as a valuable tool in formulation studies for advanced therapies

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.