Automated rapid microbiological methods for the biopharmaceutical industry: Selection, validation, and implementation for an autologous cell therapy product microbiology

摘要

Autologous cell therapy processes involve the selection of cells from a patient's biopsy and careful growth of these cells in an aseptic environment. Cell therapy products are unique because surgical implantation occurs shortly after the final production step. This presents challenges for providing assurance of product sterility due to the time required to perform a traditional sterility test. Rapid microbiological test methods offer an alternative to traditional compendial sterility test methods. A validation study evaluated the equivalence of a rapid microbiological test method to the compendial sterility test and verified that it was equivalent. Implementation of the rapid microbiological method was successful.