Applications of Osmolality in Quality Control | Advanced instruments
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Applications of Osmolality in Quality Control



Quality Control During Manufacturing

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.

Applications

Media Preparation Quality Control

It is becoming increasingly common for drug manufacturers to outsource the media and components used in their manufacturing, making QC even more critical for ensuring the quality of their processes.

In order to ensure proper environment for cell line development, each batch of media must meet predetermined osmolality specifications with the hope of maximizing yield.

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

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8 Ways That Osmolality Testing Improves Cell and Gene Therapy Processing

Reliable Osmolality Testing of High Concentration mAb Formulations

Osmolality as a predictor for model-based real-time monitoring of concentration in protein chromatography Card

Osmolality as a predictor for model-based real-time monitoring of concentration in protein chromatography (Research Paper)

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