Werum PAS-X MES: The digital EBR for providers of cell therapy

Werum PAS-X MES enables you to digitally and automatically manage your entire production process, needle to needle, for cell and gene therapies. That way, your manufacturing operations are faster, more reliable and compliant.

As a manufacturer of cell therapies, you face extraordinary challenges due to the highly complex nature of the manufacturing processes of regenerative medicines including cell therapies, gene therapies and stem cell therapies. The manufacturing execution system Werum PAS-X MES enables you to digitally manage and control your production processes efficiently and flawlessly — from the time the personalized tailored medication is ordered, to its manufacture and the dispatch logistics, and finally, to its use and the subsequent examination and infusion of the drug to the patient.

At the same time, Werum PAS-X MES enables you to manage volumes of data when many patients are involved. You guarantee that the donated cells and the medication derived from them are uniquely assigned to patients during the entire process (chain of identity). This ensures that every patient receives his or her individually personalized medicine as quickly as possible. All events along the value chain are recorded during the entire process (chain of custody). Each and every member who is part of the process gets logged (chain of compliance).

Continuously optimizing production

Werum PAS-X MES automates your entire manufacturing process. You collect all of the data as it is generated and you receive the required information digitally in real time. This enables you to monitor and continuously optimize the entire production process. For example, electronic batch recording (EBR) creates standardized digital processes for equipment, warehouse and material management. Meanwhile, master batch records (MBR) enables you to quickly and easily create and manage master batch records to seamlessly navigate the process and deliver a right first time product. 

You reduce the time and effort needed for allocating, transporting and releasing batches, and also drastically reduce the risk of human error. In doing so, you also meet all of the strict compliance requirements for providers of cell therapies. Moreover, your projects always stay within the planned budget and timeframe. And after a therapy has made its mark in clinical trials, you can easily scale it up for commercialization while having all data at your fingertips.

Leading US and Chinese manufacturers use Werum PAS-X MES

Körber is the market leader in digital manufacturing solutions for the cell and gene industry and has been an active part of the cell and gene manufacturing industry with its manufacturing IT solution Werum PAS-X MES since the first FDA approval of a therapy took place in 2017. Today, for example, leading cell therapy manufacturer Takeda uses Werum PAS-X MES for data and tech transfer at its manufacturing site in Cambridge/Massachusetts/USA. And China’s leading vaccine manufacturer, Walvax Biotechnology, has implemented Werum PAS-X MES in its Yuxi plant as a major part of its digital factory.