Pharmaceutical and biotechnology companies can use Advanced Instruments osmometers for osmolality testing extensively in their R&D, production, quality and process control operations to ensure product safety and the efficiency of their production capabilities. Freezing point technology has proven to be the industry-preferred method due to its accuracy, performance and reliability.
Advanced Instruments osmometers comply with the latest United States Pharmacopeia (USP) National Formulary Chapter 785, Osmolality and Osmolarity and European Pharmacopeia (EP) Osmolality Chapter 2.2.35.
Improved Cell Culture Yield
Cell culture has become one of the major tools used in the life sciences today used in a variety of applications including cancer research, toxicity testing, virology, drug screening & development, and large-scale cell-based production of biologicals. Enabling cultured tissue cells to retain their original morphology and function requires reproducing the tissue's natural in vivo environment. A key consideration in this effort is the osmolality of the culture medium.
When cells for culture are removed from bodily tissue, they are placed in a foreign environment and are bathed by a liquid medium, an environment where the osmolality of the culture medium, if not made iso-osmotic, can cause osmotic shock. Osmotic shock causes cell volume changes. Studies have shown that even minor short-term modulation of cell volume can change cellular metabolism and gene expression. It makes sense, then, to be aware of the influence of the osmolality of the medium being used for tissue culture. It makes sense to test for osmotic pressure, for tonicity, and to be aware that, in some cases, providing an iso-osmotic medium is crucial.
Cell Culture Process Development/Optimization
Finding the optimal mixture of culture media for a particular cell-line can be a daunting process. Since typical media powder can have 60-100 components, an exponential amount of experimental permutations are required to find the optimal “happy” media environment. Osmolality is a critical component to this testing since osmotic pressure regulates the flow of substances (media) in and out of the cell.
Media Preparation and Quality Control
Experience has proved that conscientious osmolality testing leads to higher yields and more significant observations. Because lot-to-lot variations can occur whether culture media is reconstituted or purchased, all media for the culture of both plant and animal tissue should be tested before use. Since density gradients for cell separation "want" to be iso-osmotic, significantly enhanced yields have been reported with careful osmolality monitoring. Further, maintaining the proper osmotic concentrations of fixing solutions can increase resolution and clarity in cell microscopy
Pharmaceutical Formulation Development
Salts or non-electrolytes (e.g. glycerin) are often added to protein formulations to achieve an isotonic solution. Non-electrolytes are often preferred to salts as tonicity adjustors because of potential issues salts cause with protein precipitation. Intrathecal and epidural injection drugs require very precise specifications for the product to be isotonic. Osmolality testing provides these stringent assurances
General Quality Control
Osmolality is a rapid and accurate QC measurement for a number of pharmaceutical and biopharmaceutical applications, including: finished product testing, infant formulas, ophthalmic solutions, electrolyte solutions, tissue cultures, culture media, IV solutions and other parenterals.
Bioprocess Monitoring of Therapeutic Proteins
Osmolality is a key measurement utilized to monitor the progress of fermentation within bioreactors to ensure that the process is moving forward according to plan and that contamination has not occurred.