Werum PAS-X MES: electronic batch recording (EBR) for cell & gene therapy

Werum PAS-X MES facilitates cell & gene therapy manufacturing by digital process documentation, operator guidance and review by exception. That way, your manufacturing operations are faster, more reliable and compliant.

Cell & gene therapy as well as tissue engineering processes are usually highly complex and contain many manual steps. Moreover, skilled personnel for execution and review is hard to find, which can limit the scale up of production. To address these challenges, cell & gene companies rely on PAS-X MES, which facilitates

• the documentation of the process for the operators or lab personnel by barcode scanning, automatic tracking of users, chain of identity and chain of custody
• the execution by operator guidance, automatic calculations and decisions, prevention of mix-ups, equipment checks and material usability
• the review process for supervisors and quality departments by providing a process overview, reduced probability for documentation issues and real time review by exception 

Covering the complete product lifecycle

Most cell & gene therapy manufacturers who have implemented Werum PAS-X MES are using electronic batch recording (EBR) over the complete product lifecycle, beginning with clinical trials. During this phase, most manufacturers face constant changes to the process, which provides specific challenges for the implementation of a digital manufacturing system. 

Körber has developed a best practice approach to ensure that EBR is used efficiently and feasibly in all stages of the product lifecycle. By leveraging an iterative approach of process digitization, data analysis, process optimization and validation, our customers are able to drastically reduce time to market.

Digital data management to keep up with legal requirements

Data management is particularly challenging for cell & gene therapy processes. Many new regulatory guidelines are frequently developed to stay abreast with new approvals. Furthermore, with the complex procedures, substantial amounts of data are generated and the different input material of many therapies leads to high process variability. By providing the data in a digital form early in the product lifecycle, PAS-X MES enables cell & gene therapy manufacturers to improve their data management. The digital data can be used directly with PAS-X Savvy or other data analysis tools.

Leading US and Chinese manufacturers use Werum PAS-X MES

Körber is the market leader in digital manufacturing solutions for the cell & gene industry. It has been an active part of the industry with its Werum PAS-X MES since the first FDA approval of a therapy took place in 2017. PAS-X MES can be deployed in your data center, in the cloud or fully managed as Software as a Service. 

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.

Partnering to ensure a digital cell & gene ecosystem

Cell & gene therapy processes require a digital ecosystem that reflects the specific needs of this industry segment. Companies like TrakCel and HyperTrust have developed tailored solutions for the traceability requirements in personalized medicine. Finite scheduling solutions like sedApta provide planning capabilities that take the huge complexity and process-derived flexibility into account.

Körber has partnered with these, and other world class solution providers, for many years to provide easy and best practice integration of PAS-X MES into a perfect cell & gene therapy digital ecosystem.