Biopharmaceutical manufacturing involves many complex operational steps. Ensuring that the
manufacturing process consistently produces a biopharmaceutical product of predetermined yield,
purity, and quality is of utmost importance. To ensure a quality manufacturing process is achieved the
use of process analytical technology (PAT) should be used. Osmolality as a PAT can be used to monitor
raw material components, process intermediates, and finished products.

Solute concentration in process fluids is an important parameter required in bioprocessing to achieve
consistent results in process fluids. Osmolality is a measure of concentration and is considered a critical
quality attribute and critical process parameter in bioprocessing.