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 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.

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 ...

Not only does the practice subject process equipment and raw materials to damaging conditions, it can lead drug manufacturers to opt for aseptic processing in cases where terminal sterilization would ...

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.

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 ...

From the topics listed above the areas covered provide the mathematical means of developing and proving the sterilization process is effective and does not generate a problem for heat liable products.

NovaSterilis Inc., a developer of supercritical carbon dioxide technology, has been granted US Patent 8,012,414 B2. The patent, dated September 6, 2011 entitled "Sterilization of Drugs Using ...