Osmolality Testing: Providing Unique Process Control for Downstream Operations

Osmolality is a well-established parameter for upstream bioprocessing, formulation, analytical development and QC applications throughout the manufacturing of biological drugs. A recent publication details the use of osmolality as an in-process parameter for purification, providing a predictive modeling parameter for protein concentration. This application is being investigated across protein and viral vector modalities, and there is clear value in testing osmolality during buffer preparation and filtration operations as well.

 

Given the increasing prominence of osmolality as a process control and quality parameter in bioprocessing, Advanced Instruments offers a portfolio of osmometers designed specifically to fit Pharma and Biotech compliance needs. The OsmoTECH® portfolio of osmometers from Advanced Instruments deliver the highest level of data management, accuracy and precision, and ease-of-use available on the market today. They provide valuable concentration measurements while also offering features that support GMP, 21 CFR Part 11, and EU Annex 11 compliance.

 

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