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 […]
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