To ensure the sterility of parenteral biopharmaceutical products, it is necessary to employ certain tools, technologies, and standard operating procedures. Aseptic sterile filling is one of the most critical processes in biomanufacturing and is driven by the highly technical nature of these processes as well as the potential safety impact to the end user (1). For biologics fill/finish operations, process design must take into account the innate properties of proteins and the external factors that can affect a given protein’s behavior and stability, and special processes, procedures, and equipment should be in place to ensure product integrity during fill/finish (2). Click Here For Complete Article Text
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