The Digital Dream

Whether it's ready or not, an automated, paperless cell and gene therapy manufacturing industry has emerged. But how will it affect everyday operations, global megatrends in sustainability and the environment, and the primary endpoint of improving the lives of patients?

Paperless manufacturing enhances the sector’s sustainability by reducing resource consumption, waste, and carbon footprint. Traditional manufacturing relies heavily on paper-based documentation for batch records, SOPs, and quality control records. Moving to digital systems eliminates the need for printing, storage, and disposal of these documents, reducing the consumption of paper, ink, and energy.

Digital platforms also provide the elements required for scaling, resulting in improved data management and traceability, process streamlining and efficiency increases, and collaboration and knowledge sharing. With controlled inputs, QA teams can apply “release by exception,” speeding up therapy releases and minimizing non-conformance. Real-time and remote data access improve stakeholder alignment and communication, increasing efficiencies across the ecosystem. Capturing and sharing process data drives sector-wide innovation, advancing therapies and ensuring the sustainability of business models for these innovative modalities, but to derive this from paper-based manufacturing is highly challenging and time-consuming.

Digital transformation, either from paper or other less-than-adequate digital tools, is often deprioritized due to the resources and time required to discover and test potential solutions. The process of choosing a provider is arduous and resource-heavy. Between cross-functional alignment, sales team interactions, and limited exposure to prospective “software as a service” (SaaS) products, it can take many months to go from inspiration to viability testing. In short, it is difficult for teams to collectively prioritize digital manufacturing. At the same time, software companies have been known to make digital planning burdensome rather than offering self-service empowers manufacturing teams to take the crucial first step in their own time and provide the tools to explore the accessibility of digital manufacturing. The key is to make digitization more accessible. 

The evolving nature of cell and gene therapy modalities and the understanding that data drives scientific and operational efficiency make digital planning an imminent need in this sector. Early-phase or underfunded manufacturers face a catch-22 situation with digital investment. Existing systems are often rigid, requiring third-party service teams to configure each process iteration, leading to significant costs and delayed timeframes for capturing early-phase process data where iterations are frequent. Consequently, manufacturers might delay digital adoption until processes are more mature, sacrificing valuable early-stage data. Here, it’s important to note that purpose-built solutions for the cell and gene sector do exist – and they offer controlled agility and self-reliant iteration cycles without the need for third-party services. 

Cloud-based records enable the engagement and alignment of an entire ecosystem, including frontline care providers and researchers. They allow for a comprehensive view of a patient’s diagnostic state and care journey in numerous ways, including personalized output conversion, complete preparedness for upcoming phases of care, and the evolution of therapy development through monitoring and data-driven iteration

Specific positive impacts of electronic batch records include improved data integrity and traceability, problem detection, recall (if required), real-time monitoring and quality control, proactive critical process parameters monitoring, quality standards, risk assessment, reduced human error, automated data collection and analysis, data accuracy, enhanced collaboration and communication, regulatory compliance, and a comprehensive audit trail – all of which combine to reduce the risk of adverse events in patients.

However, manufacturers should understand the limits of a cloud-based platform’s flexibility and adaptability. Ask yourself these questions: Will this platform provide the configuration agility necessary for the variability and highly iterative nature of cell and gene therapy development? Will it provide a self-reliant configuration experience or a hefty investment in third party services?

Consider how intuitive or easy to adopt the system is. Ease of use promotes cross-functional collaboration. If the system is highly intuitive, adoption will be easy and significantly faster. If (a lot of) nuanced training is required, adoption will be challenging. 

Assess how well the platform will complement your existing infrastructure – and also explore how it will adapt to future needs. Consider existing system integrations across other critical systems and, again, ask yourself a question: Does the provider approach integration projects with a simple and accessible project deployment, and at what cost?

A paperless CGT manufacturing industry will revolutionize the field by being more efficient, agile, and transparent, leveraging digital technologies to improve product quality, reduce costs, and accelerate the development of life saving therapies for patients in need. It will also lead to a more responsible industry as digital workflows will eliminate the risks of misreading instructions and mistakes made during manual data entry. Advanced analytics will leverage historical and real-time data to predict potential issues, allowing manufacturers to take preventive measures, minimize downtime, and reduce waste. And manufacturing facilities could become remotely accessible through secure networks, allowing authorized personnel to monitor operations, troubleshoot issues, and make adjustments from anywhere in the world. 

In my view, a paperless industry will significantly benefit science and patients alike, bringing prosperity to all.