A Perspective On Various Use Cases Of Osmolality In Quality Control

By Kendal Studd, Scientific Support Specialist; UK, EMEA & APAC, Advanced Instruments, LLC

Osmolality as a quality control parameter has long been a required and necessary test for determining the concentration of solutes in solution within the clinical market, but its relevance has since become more prevalent in the biomanufacturing sector. Checking the accuracy of reconstituted products and determination of the desired final concentration of injectables to be administered parenterally is of critical importance to drug manufacturers. Quality control, or QC, plays a big part not only within pharmaceuticals, but in various other biotech sectors, with the aim to achieve a reproducible and consistently high-quality product.

Osmolality testing may be undertaken by an internal QC laboratory or outsourced to an external company; both having a significant impact on whether that product can move forward through production and manufacturing. Keeping to specification is critical throughout the bioprocess workflow, from hydration of the media used for culturing cells to confirming buffer specifications prior to UF/DF (Ultrafiltration/Diafiltration) process steps through to final formulation quality checks. The incorporation of osmolality testing into these processes allow for easier and quicker identification as to where these solutions may be deviating from specification. With the introduction of Advanced Instrument’s freezing point depression osmometers, the measurements are now fast, efficient, and reliable due to the ever-evolving gold-standard technology.