Abstract: An acoustically resistive protective cover assembly for an opening in a casing is provided, the casing separates an enclosed space from the ambient space and has an exposed face oriented toward the ambient space and an internal face oriented toward the internal space. The cover assembly comprises an acoustically resistive porous material disposed upon the exposed face of the case and an acoustically resistive water repellant material disposed upon the internal face of the case.

Abstract: An acoustically resistive protective cover assembly for an opening in a casing is provided, the casing separates an enclosed space from the ambient space and has an exposed face oriented toward the ambient space and an internal face oriented toward the internal space. The cover assembly comprises an acoustically resistive porous material disposed upon the exposed face of the case and an acoustically resistive water repellant material disposed upon the internal face of the case.

Abstract: The manufacture of cellular product such as a protein by expression from a cell line in a bioreactor is carried out wherein the bioreactor is a container made of flexible film, at least the interior surface of the container being fluoropolymer, and in addition, the nutrient medium and other agents used in the fermentation or cell culture process can be prepared in a separate container of the same film.

Abstract: A process for the production of therapeutic protein is provided, which includes the steps of preparing nutrient medium for culturing of cells to express the protein, culturing the cells in the presence of the nutrient medium to express the protein, preparing protein separation solution for isolating the protein, formulating the isolated protein, and storing the formulated protein, at least three of these steps being carried out in separate disposable containers made of flexible film, at least the interior of said surface of said container being made of fluoropolymer.

Abstract: A package is provided, comprising a fluoropolymer bag and an overwrap, the package being terminally sterilized so as to obtain and maintain the sterilization condition of the fluoropolymer bag, which can then be made available as a sterilized, disposable vessel for biological material and corrosive reagents.

Abstract: A flexible container is provided of flexible film, the interior surface of the container being fluoropolymer, the container being applicable to the storage and/or preparation of protein separation solution used in the chromatographic purification of protein, such as therapeutic protein.

Abstract: Therapeutic protein is formulated in a container made of flexible film, at least the interior surface of said container being fluoropolymer, which is preferably terminally sterilized in a sealed overwrap so as to be available for the formulating step in sterilized condition.