In recent years, the Biopharmaceutical industry has experienced rapid growth and innovation through many different therapeutic modalities. One of the challenges the industry faces is finding efficient ways to monitor critical quality attributes (CQAs) throughout the bioprocess, such as pH, metabolites, endotoxin levels, product concentration, and osmolality. While the industry moves toward more automated processes, it is of utmost importance to maintain confidence in decision making early in the bioprocess to ensure a safe and effective drug product further down the line.
For many different drug product technologies, osmolality is a common CQA monitored throughout the bioprocess. Osmolality is commonly tested in raw material QC, solution preparation, cell culture monitoring, buffer exchange monitoring, stability testing, final product QC and release, and much more. To follow industry trends of automation and higher throughput, Advanced Instruments has developed the first 96 well plate-based osmometer available to the market, called the OsmoTECH® HT. Automated high throughput testing is valuable to many labs as it provides significant time and cost savings, while reducing human error. High throughput testing of osmolality is especially critical for formulation development workflows, in which many different solutions must be evaluated in a short period of time. Notably, formulations involving lipid nanoparticles (LNPs) containing genetic material must be carefully monitored, as LNPs are osmotically sensitive and require precise isotonic conditions to prevent premature rupture (1).
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