Using Quality Control (QC) throughout the manufacturing process ensures biopharmaceutical products are consistently produced to a predetermined yield, purity, and quality. QC is used to measure that the osmolality of drug products are within set standards throughout manufacturing and can be plugged in upstream, downstream, and during final product release.
To ensure a quality manufacturing process is achieved, process analytical technology (PAT) should be used. Osmolality as a PAT can be used to monitor raw material components, process intermediates, and finished products.
Osmolality is the total number of solutes in a liquid solution expressed in osmoles of solute particles per kilogram of solvent. Osmolality is not dependent on volume; it is not affected by a change in the solution’s temperature therefore it is an ideal PAT.