Introduction
Each year, leaders of the industry gather at Advanced Therapies Week to share best practices and discover emerging technologies. In January, brand owners, CDMOs and OEMs alike gathered in Miami, FL to learn and grow in this ever-evolving field. At Rockwell Automation, our goal is to help you bring products to market faster with control and quality required of GMP manufacturing. While in Miami, we attended expert-led sessions, spoke to those in the field and even got the chance to present on the importance of integrating digital technologies in your manufacturing process. From these experiences, we have noticed some key takeaways.
3 Key Challenges & Solutions
Meeting Patient Demand
Innovation in Advanced Therapeutic Manufacturing has been incredible: tailored therapies to the patient while maintaining compliance. But the challenge is, how do you get these new therapies to patients while meeting growing demand? You know how to meet the demand of a singular patient, but how do you keep up with producing multiple individual therapies for many patients at the same time? Many organizations are leveraging CDMOs and distributed manufacturing to scale up operations. At Rockwell Automation, we understand the needs you have when it comes to scaling your operations to meet demand. Enabling Tech Transfer and collaboration means you can have visibility between Sponsor Organizations and CDMOs allowing you to track your data and maintain production within FDA guidelines. Providing control via PlantPAx® and FactoryTalk PharmaSuite® will help you deliver consistent quality and control by automating processes and eliminating the need to store and maintain paper records. Electronic Batch Records also can help eliminate the paper reliance processes and reduce quality review time, which can shorten product release times. Utilizing MES in your operations can help alleviate the pain of manual entries and long cycle review times and allows you to scale operations to get your product to patients faster.
Requirement of New Innovations
As new therapies are being developed, new technologies are required to scale up operations to meet patient demand. The challenge is integrating your new technologies into a comprehensive system for GMP manufacturing. The new equipment that is installed must be connected to a data management software that allows for improved quality and control for your product. The value of an MES rests in the business strategies which allow you to leverage technology to realize ROI. Utilizing Rockwell Automation’s scalable and open architecture platforms allows for bench-top scale production and IIoT integration of equipment to ensure production meets compliance and integrity requirements. Supporting IIoT with an MES solution helps reduce challenges in bringing new therapies to patients by bringing together all of your data into a single, trackable metric like a lot, batch, or serial number.
Managing Data Across the Value Chain
We know that controlling the supply chain is critical to ensuring therapies are getting to the right patient. In Autologous therapies especially, where modified cells from a donor or patient are harvested, modified, and then infused with the patient, the biggest challenge is managing all that data. From collection to injection, there is a mountain of data that must be collected and tracked to ensure that the newly created therapy is going to the right patient and meets quality standards. Chain of custody and chain of identity tracking through the supply chain needs to be integrated with the production data and electronic batch records. With all of the data produced, it is key to have an industry-leading solution, like FactoryTalk PharmaSuite®, to manage and deliver a single version of the truth to provide batch-to-batch control and enable easier quality review and audit responses. Integrating your systems into a single “data lake” allows you to also evaluate production parameters and key goals across multiple batches and multiple product lines by gathering data from your supply chain, batch records, and all integrated equipment.
Conclusion
Attending Advanced Therapies Week provided insight into what customers need, their challenges, and common roadblocks to manufacturing success. From the challenges of meeting patient demand, to managing all the data that comes along with the production of targeted therapies, at Rockwell Automation we believe that with these new industry insights we can help improve outcomes at your facility. Trusting us to propel you into the next stages of your manufacturing journey through digitalization can help you ease scaling and improve time to market while increasing visibility across your supply chain. We work closely with your experts to support your growth and help you achieve your goals through a more productive digital environment.
