The article, which provides recommendations to aid in the evaluation and development of terminal sterilization processes, is published in the peer-reviewed journal Nucleic Acid Therapeutics.

submission of products labeled as “sterile” to undergo industrial terminal sterilization processes based on microbial inactivation. The guidance updates a 2008 FDA document and now includes ...

Therefore, “immediate use-sterilization” should be kept to a minimum and only used when there is insufficient time to process by the preferred terminal sterilization method. “Immediate-use ...

Production of patient-specific cell-based therapies (PSCT) presents unique scale and cost challenges not seen in pharmaceuticals and biologics manufacturing. Rather than scaling up to increase ...

The recommended practice states: NOTE: Refer to the device manufacturer’s instructions to determine whether decontamination using microbicidal processes is required after cleaning and before terminal ...

Q. What is aseptic processing? A. Aseptic processing is a manufacturing method that can produce product that is absent of bacteria without subjecting the product to terminal sterilization processes.

The article, which provides recommendations to aid in the evaluation and development of terminal sterilization processes, is published in the peer-reviewed journal Nucleic Acid Therapeutics.