Applications of Osmolality in Quality Control

Buffer Preparation Quality Control

Failure to identify composition issues in your downstream buffers could result in product deviations down the line in the manufacturing process. Osmolality testing should occur during buffer QC and as an in-process parameter during purification to ensure that measurements are within specification.

Using osmolality to identify and detect impurities early in your process saves on operational costs and eventual product yield.

Learn more in our Application Note – Osmolality as a concentration measurement method for key buffers in bioprocessing.

Formulation & Final Product

Osmolality testing has long been considered a compendial measurement for the release of biological drugs (FDA), as any substance entering the body must be physiologically isotonic.

Final product QC and compendial testing is required to ensure the quality and safety of your drug product for patients. Without this final quality control check, there is a risk of unwanted impurities and contamination, resulting in batch deviations. Because of this, there is the potential for a decline in patient compliance. An unexpected osmolality for your product can then produce negative side effects when introduced into human tissue, causing pain at the injection site, as an example.

Osmolality testing is commonly used as a release specification to confirm the quality of drug products and ensure that they meet regulatory requirements for quality.

Learn more in our formulation webinar