The road to commercial manufacturing for Cell & Gene therapies
Werum’s PAS-X MES targets the key challenges for cell therapy manufacturers, managing complex processes and controlling the chain of identity
Imagine you are an up and coming cell therapy company. You have gone through the exploration phase, and are in the process of finalizing a breakthrough treatment.
When scaling-up to commercial manufacturing, electronic systems are emerging as the only option for managing complex processes and controlling the chain of identity.
Werum’s PAS-X MES is ideally suited to target the key challenges for cell therapy manufacturers through its capabilities to automate calculations and workflows.
PAS-X MES and its role in cell therapy
Electronic batch records increase quality through standardization and elimination of paper, while equipment, inventory and material management streamline the process.
This white paper discusses the unique biopharmaceutical supply chain challenges of Cell & Gene (C&G) therapy logistics and recommends forward-thinking solutions to address them. Successfully overcoming these logistics challenges is essential in order to scale up C&G therapies to treat large numbers of patients worldwide. The white paper is intended for people working in autologous or allogeneic therapy supply chains, manufacturing operations, quality control or IT departments of C&G therapy companies close to obtaining therapy approval or scaling up to commercial manufacturing.
Electronic systems are emerging as the only option for managing large patient volumes. Werum’s PAS-X MES is ideally suited to target the key challenges for Cell & Gene therapy manufacturers.
This white paper addresses the unique production problems of cell and gene therapy and explains how a manufacturing execution system (MES) can address them. It provides guidance on how to select an MES and a case study of two CAR-T therapy companies scaling up with and without an MES.
Cell Therapy and Gene Therapy: A Case Study on scaling up for Commercial Manufacturing, presented by Mucahit Agirtmis, Sales & Business Consultant, Werum IT Solutions.
Watch our new video and learn more about our digital solutions for Cell & Gene therapy.
PAS-X has the ability to track and control patient’s material from collection through infusion, provides full Electronic Batch Recording (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, PAS-X Master Batch Recording (MBR), 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.
Future-proof your manufacturing process now!
PAS-X meets the challenges of the industry
The past years have seen rapid growth in the number of cell therapy products in late stages of clinical trials. However, moving closer to market-approval brings significant operational challenges for companies as their patient populations grow.
Electronic systems are emerging as the only option for managing large patient volumes. Werum’s PAS-X is ideally suited to target the key challenges for cell therapy manufacturers.
We are excited to play a role in the fight to save lives of those who have no other chance of survival. Our vision is to be the solution provider and partner to the Cell & Gene industry by perfecting our comprehensive solution set and services, providing best-in-class scalability, productivity and compliance.
Executive Vice President & General Manager
Werum IT Solutions America, Inc.
What we offer
Werum’s PAS-X guarentees an on-time and on-budget project, tailored to your needs for the Cell & Gene therapy industry.
- One-stop supply for comprehensive solution set
- Highly configurable and extendable solution
- Extensive process understanding
Review by Exception
- PAS-X electronic batch records eliminate the need for paper on the shop floor, as well as provide the ability to review by exception, reducing the per-batch effort needed.
Raw Material Traceability and E-logbooks
- PAS-X provides a platform for Point of Use Verification of critical production components and realtime building of product genealogy. By scanning during the process, an e-logbook is created that manages batch history.
Process Quality Control
- This feature of PAS-X ensures continuous monitoring of production quality. This supports process-analytical, on-line and at-line quality control.
Material Tracking/Chain of Identity
- PAS-X secures the in-plant material flow throughout the entire process by utilizing barcodes and transponders, uniquely identifying patient material. In an industry where time is limited, PAS-X reduces risk of mixups and ensures the material gets to the patient on time.
Due to our experience implementing our PAS-X system at a number of cell therapy sites, Werum has developed specific cell therapy content within our MES software.
- Specified content for the cell and gene therapy industry
- Easy and fast setup of PAS-X MES
- Industry best-practice based configuration
- GMP Ccmpliance
- Accelerated MBR creation
- Process harmonization
Ability to scale up and scale out
- PAS-X possesses the ability to grow with your company, offering a number of different approaches. These range from modular software to a process or location-specific approach.
Industry consultants and experience
- We offer a comprehensive set of consulting services and dedicated consultants with the skills and expertise to design and create MBR’s for the cell and gene therapy industry.
- We can provide turnkey project implementation including validation training and project management.
CAR-T business case
One of the main challenges for CAR-T manufacturing is batch record review. Since each patient is one batch, and each batch record could be thousands of pages, the amount of paper records that would be generated would quickly become unsustainable.
A current CAR-T customer’s calculations show 30 hours are required to review one batch record using manual paper processes. With a PAS-X MES implementation, the time for review is reduced to 4 hours per patient.
PAS-X implementation reduces the amount of manual processing steps per batch. For example, date/time and calculation steps are now completely automated. The overall effect is a reduction in recording steps by 83%.
Patient data is available electronically in real-time analysis, helping with continued process optimization and KPIs
Reduction in per batch execution effort and risk of human error
Increased data quality, enforcing correct material usage and preserving chain of identity throughout the entire process
Ability to look at batch records and review deviations in real-time