Together with its Körber partner companies, Werum is working on solutions that help streamline the complex cell and gene therapy workflows and enable delivery at scale of these critical, life-saving and personalized medicines.
1. Speeding up treatment for patients - Getting the treatment to the patient as quickly as possible.
Solution: MES enables manufacturing automation by reducing manufacturing time and risk. This is accomplished by eliminating paper processes, reducing the amount of time needed for batch record review by being the first quality check, and automating manual workflows like recipe review and batch record approval.
2. Right first time, every time - Many factors can attribute to errors that will delay the release of treatment, especially manual data entry. However, when time is of the essence, each treatment must be manufactured correctly the first time.
Solution: MES helps ensure right first time manufacturing by reducing human error. Real-time deviation management will catch mistakes during each step rather than at the end. This constant checking and confirmation is the best way to prevent having to ask patients for another batch.
3. Scalability - Once a therapy is proven a success, it’s time to help more patients. That means scaling up manufacturing without drowning in paper. With paper-based tracking, every patient’s therapy requires hundreds to thousands of pages that need to be manually reviewed.
Solution: MES supports scalability by capturing manual entries in the batch record (often reducing the number of manual entries by up to 80%), checking and verifying values as they are entered, and replacing manual calculations with automated ones.
4. Chain of Identity (COI) and Chain of Custody (COC) - Ensuring the right patient gets the right treatment includes tracking and ensuring COI for each patient throughout the process. Similarly, COC ensures chronological documentation that records the sequence of custody, control, transfer and analysis, not just in manufacturing but throughout the logistics and treatment processes.
Solution: MES helps confirm COI and COC during manufacturing. MES uses material tracking technology to ensure that the correct materials/ apheresis bags are used in the correct treatments. MES also ensures patient kits and lot genealogy are tracked and fully traceable.
5. Manufacturing Intelligence and analytics - In paper-based processes it is difficult to capture data, monitor and analyze what’s happening let alone gain new insights.
Solution: MES captures all data electronically, presents it in dashboards, and analyzes it for process feedback, insights and improvements. This is especially important in cell therapies where the processes are still changing and evolving. The more data that is available the more valuable the system becomes over time.
Werum’s PAS-X MES has the ability to track and control patient’s material from collection through infusion, provides full EBR to the plant and increases compliance. This helps to greatly reduce the time required for batch disposition and release, as everything is tracked and addressed in real-time. What’s more, MBR functionality, through its user-friendly design and ability to create process libraries, offers a way to expedite recipe creation. Moving to EBR greatly reduces the time needed to make updates to recipes, which is constantly happening in cell therapy – even after commercial manufacturing is achieved.
Together with its Körber partner companies, Werum is working on solutions that help streamline the complex cell and gene therapy workflows and enable delivery at scale of these critical, life-saving and personalized medicines.
Click here to download our whitepaper, Paperless Manufacturing for Cell Therapy.
