Pharmaceutical Quality Control
Osmolality testing has long been considered a compendial measurement for pharmaceutical quality control and the release of biological drugs (FDA), as any substance entering the body must be physiologically isotonic. 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.
Media Preparation Quality Control
It is becoming increasingly common for drug manufacturers to outsource the media and components used in their manufacturing, making quality control of culture media 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.
Help Ensure the Quality of Your Media to Help You Maximize Yields and Provide a High Quality Product to Your Patients
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,
Very easy to use for all technicians in a quality control lab. Small sample size. Friendly technicians that explained how to use the product very well.
Cathy Gladkowski, Biologos LLC
Popular Educational Resources
Learn more about how osmolality can be utilized to help ensure quality control of your drug product by checking out our educational resources below
Whitepaper
8 Ways That Osmolality Testing
Improves Cell And Gene Therapy
Process Development And Manufacturing
Associated Products
OsmoTECH® XT Single-Sample Micro-Osmometer
Best-in-class osmolality performance, designed for the toughest samples
OsmoTECH® PRO Multi-Sample Micro-Osmometer
Combines ease-of-use with accurate and precise measurements for reliable results
Bioprocessing Services
Get the best performance from your osmometer from the people who designed and built it. We provide a range of services and service plans to meet the different needs of our customers.
Our certified Field Service Engineers provide on-site professional support for the installation, training, validation, and maintenance of your osmometers.
