Osmolality is a key process parameter in cell and gene therapy
Such innovative approaches require a robust bioprocessing workflow – from research to product development to GMP manufacturing. Therefore, precise and accurate process control strategies – such as the use of osmolality testing – are critical to optimize the product yield and help drug developers overcome the obstacles of poor performance. Because osmolality is one of the most important process control parameters, testing it can ensure purity and consistency of biopharmaceutical products throughout the bioprocess workflow, from upstream to downstream and to the final formulation and filling process.
“Osmolality testing is crucial for process development, analytical development and GMP testing. We need to meet the regulatory requirements for the product to be released to the market or to be released to go to a patient.”
Kayla Pasake, Research Associate for Analytical Development at The Center for Breakthrough Medicines
“When we purchased the Advanced Instruments OsmoTECH XT, we were in start-up mode in the labs and developing our assays,” Pasake says. “At the beginning, we needed a small, easily transportable osmometer. At the same time, we needed an instrument we could also use later on when we would finally move into the GMP phase.“ Pasake’s requirements exemplify optimal bioprocessing development: the ability to use one instrument to meet a range of requirements during process development and, later, GMP manufacturing. By using one instrument to meet these requirements, scientists can address and resolve potential manufacturing concerns early in process development. This accuracy and efficiency saves both manpower and money later in the scale-up phase1.
Osmometers need to accurately measure the widest variety of sample types
Osmolality testing has a very broad range of applications: from maintaining optimal cell growth to ensuring active pharmaceutical ingredient purity and yield or confirming quality during fill and finishing. “When you are in the process development stage, you need an osmometer with a wide range,” says Pasake. “That wide range is what is key, and that’s also what stood out for us with OsmoTECH XT. In the beginning, you never know which kind of samples you’re going to test, and this osmometer offers an amazing range of osmolality testing: from 0 to 4000 mOsm/kg H2O.”