So how exactly are innovative software solutions like Körber's Werum PAS-X going to help us meet these challenges?
As said, the production processes in cell and gene therapy are of high complexity – from cell sampling via the tailor-made manufacturing procedure to the actual patient treatment. Herein lies the source of numerous errors that are potentially life-threatening – particularly when the assignment of therapeutic agent and patient is carried out manually.
Digital Manufacturing Execution Systems such as Werum PAS-X MES greatly simplify both the establishment and documentation of this Chain of Identity. Hence, they can help to ensure that the coherent cells arrive at the right patients. Additionally, they support the Chain of Custody by recording and monitoring all events, the devices used and the participants involved throughout the entire process.
Our customers can digitize the entire production process, collect all the data they need and obtain all the relevant information in real time - whether it's managing equipment, inventory and materials, documenting the process with Electronic Batch Recording (EBR) or administering manufacturing recipes with Master Batch Records (MBR).
And finally: When all data is available digitally, you can react quickly and flexibly to new conditions, as this was the case during the COVID-19 pandemic, for example. Also, the legal situation is progressing for these new therapies, as the approval criteria of the responsible U.S. authority, the FDA, and the EU authority, the EMA, are also adjusted as new findings emerge.