Cell & Gene Therapy
State-of-the-art individual personalised medicine requires state-of-the-art analytical methods. Because these therapies often have a very limited life span and therefore depend on a particularly fast test which checks the microbiological load or guarantees sterility. This is the optimal application for GramRay.
Various further developments, such as personalised medicine, lead to batch size 1, e.g. for patient-specific gene therapies and cell-based products. This leads to new challenges in microbiological quality control.
Rapid microbiological methods (RMMs) are essential for the modern production efficiency of cell and gene therapies, as traditional test methods cannot work with shorter test times or with the small sample volumes. Some cell and gene therapies require a manufacturing process and a release time of only a few days.
GramRay is the new tool in the areas of quality and in-process control. It also provides the right answers to the regulatory environment and regulatory questions.