Nearly every aspect of medical treatment from development and production to application includes the use of a sterile filter. Filtration is important to keep chemicals and pharmaceuticals clean, pure, and free of pathogens. For instance, heat-sensitive compounds such as antibiotics and vitamins, are filtered before adding them to sterile cool media.
The chemical industry has developed a membrane using a high grade polyvinylidene fluoride (PVDF) resin used to manufacture best-in-class sterile filters. The membrane is used to eliminate contamination of pathogens from multiple drug and biotech product unit operations such as buffer filtration, cell culture media filtration, prefiltration, process intermediate filtration, gas filtration, and final product sterile filtration. Amongst other benefits, this membrane offers low protein binding, non-fiber releasing, and low extractables with broad chemical compatibility making it ideal for critical life science applications. No alternatives exist that combine these properties.
Since the PVDF membrane is ideal for multiple quality control tests and for the preparation of biological materials used in academia and other advanced research institutions, it is found in many production sites and research laboratories at leading pharmaceutical and biotech companies worldwide. Resulting therapeutics are used to treat a variety of diseases including cancer, diabetes, auto-immune diseases, infectious diseases, heart disease, and neurological disease.
Given that many functions and applications of the membranes cannot be considered as medical devices or IVDs, the elimination of this membrane from the (bio)pharmaceutical manufacturing industry would create a disruption to the supply of life-saving and life-enhancing therapies worldwide.