5 Benefits Of Using MES For Cell & Gene Therapies
By Lynette Nazabal and Sydney Epps, Clarkston Consulting
In a previous article, we shared some key considerations for the manufacturing execution system (MES) vendor selection process for life sciences companies. On the rise within life sciences is the fast-moving growth of cell and gene therapy (CGT) companies, which have their own set of unique complexities and challenges in manufacturing. It is valid to question whether these same MES solutions would be right for your CGT manufacturing operation. MES vendors recognize this as well, which is why they have evolved solutions specially designed for CGT manufacturing to help you prepare for commercialization while meeting the unique challenges that accompany these complex processes.
Let’s look at how an MES can provide targeted solutions to help mitigate five of the top challenges in the manufacturing and commercialization of cell and gene therapy.
1. Automating Manual Processes
CGT is a complex and quickly evolving landscape that still employs highly manual processes for tracking patient samples, recording data, and operating instruments. Several manufacturers record all batch records, perform process calculations, and count cells manually. At a small scale, manual processes can increase the flexibility and security of record keeping. However, they also can be error-prone, difficult to manage, and pose a challenge in commercializing operations.
Many CGT manufacturing processes rely on paper batch records, which can be time-consuming to maintain, prone to human error, and cost valuable talent that can be applied to other tasks to improve operational efficiency. An MES can significantly reduce the manual labor requirements by automating calculations, integrating systems, providing user work instructions, and performing operations based on verified standard operating procedures. Taking things a step further than automated closed systems, MES are highly adaptable and establish a digital network to allow greater control and quality assurance of the manufacturing process.
2. Digitizing Manufacturing Data
Utilizing paper batch records, manual equipment logbooks, and complex instrumentation can create challenges in CGT manufacturing. An MES enables a digital environment with electronic batch records and data storage platforms to make data capture more efficient, effective, and flexible. Digitizing manufacturing data enables centralized storage with easy-to-review capabilities and automated tools for quality assurance to expedite the approval process. In addition, real-time manufacturing data can provide visibility to activities occurring on the shop floor and allow for development of advanced analytics for manufacturing operations.
Considering these benefits, there must be a reason more companies haven’t made the switch to paperless data management, right? Due to continuously evolving manufacturing procedures, it can be difficult to implement robust electronic processes in a timely manner. Thus, it is vital to implement your MES as early as possible to digitize processes and enable larger-scale operations from the start. Establishing this comprehensive digital data management early on allows for high visibility and an easily accessible repository of historical records.
3. Maintaining Traceability
Chain of identity and chain of custody take on a whole new level of importance when it comes to CGT manufacturing. In allogeneic and, especially, autologous cell therapy, effective chain of identity management is crucial. Patients and materials must be tracked from cell extraction through the entire manufacturing process and finally to patient delivery. It is vital that data be accurately recorded at every stage so that it is easily accessible for analysis and comparisons across batches.
This can be difficult to achieve when operations are highly manual. MES helps to mitigate these challenges and improve the chain of identity through automated material flow, embedded barcoding for material checks, and by ensuring proper procedures through limits, dialogue boxes, and warnings in the digital system. Additionally, CGT orchestration platforms are offering features specifically designed to improve product tracking throughout the supply chain and integrate all components of the manufacturing process. With MES solutions also offering user-friendly interfaces to connect all process components, visibility is greatly increased, and all operations can be monitored across the digital supply chain.
4. Adhering to Regulatory Requirements
With critical timelines in CGT and the inevitable quality issues that come with any manufacturing process, it is vital to ensure systems are in place to manage operations and data records to prevent deviations and immediately address quality concerns. In CGT, regulatory compliance is about more than following guidelines; it is about producing efficacious and safe treatments for patients. It can be challenging to standardize and implement GMP guidelines across multiple sites while maintaining compliance with regulatory requirements.
MES can not only help to reduce errors on the individual batch scale by digitizing and automating processes but also can help expedite the quality review and release process that is often lengthy and cumbersome with manual data capture. Many MES solutions offer review-by-exception and deviation tracking within the batch record to help create a more concise and consolidated view of activities within manufacturing while still maintaining compliance.
5. Expediting Production Timelines
CGT companies face several obstacles to large-scale commercialization but at the core, improvements in efficiency are key to enabling scalability. Companies must prioritize digitization to automate processes, enabling them to streamline operations and cut down on turnaround times. An MES can help to reduce process errors and enable review-by-exception practices to save time by preventing deviations and mitigating issues quickly with a targeted approach. Especially in autologous gene therapy, it is important to operate efficiently and maintain high visibility of the supply chain to prevent delays to patient delivery. Integrated MES solutions can do just that while also increasing the bandwidth of companies to make treatments accessible for a wider range of patients.
An MES has an extensive list of benefits related to increasing the efficiency of manufacturing operations, but it is vital to approach an implementation strategically and early to maximize benefits as companies reach commercialization and scale.
Conclusion
An effective MES is going to be essential to the successful commercialization of your cell and gene therapy manufacturing process. From the reduction of manual processes to improved site integration through digitization, an MES will help reduce error, ensure compliance, and expedite project timelines. Integrating any new system into a company’s existing infrastructure can pose challenges. It is paramount to select the correct vendor and ensure the system you implement meets your business needs and the long-term strategy of your company.
About The Author:
Lynette Nazabal is a client solutions executive with Clarkston Consulting and serves as the firm’s pharmaceutical, biotech, and contract manufacturing and research organization lead. She has worked within the pharmaceutical and biotech industry for almost 18 years, with differentiated experience that includes quality systems, laboratory operations and technology, validation, and regulatory operations and compliance. Nazabal also has considerable expertise in manufacturing execution systems, with a specific focus on batch record design, master data management, business process flow, training, and project management.