European Pharmaceutical Manufacturer: Platform Technologies to Scale Up

Cell and gene therapies (CGTs) have marked a significant advancement in treating diseases since the 1970s, with the first patient treated in 1990. Despite their promise, scaling from lab to commercial production remains a hurdle, plagued by complex processes and costs limiting access. An FDA official forecasts 2024 as pivotal for overcoming these challenges, underscoring the importance of scalable production and early attention to critical stages like fill/finish to ensure product integrity.

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The unique biological properties of CGTs demand meticulous handling and processing, rendering conventional sterilization and small-scale methods insufficient for commercial needs. This highlights the necessity for technologies that can meet these specific challenges efficiently while ensuring contamination prevention—an essential factor due to the severe risks contaminants pose to patient safety. Automation and barrier technologies play key roles in maintaining sterility, necessitating a balance with accessibility to manage any issues effectively.

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Adaptable platforms are emerging as solutions to meet CGTs' many manufacturing demands, requiring careful selection of components compatible with CGT standards. Addressing the skills gap in manufacturing and GMP practices is critical for leveraging new technologies from research to commercial production stages.

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As the sector evolves, to avoid bottlenecks in delivering these transformative therapies, early planning and collaboration with industry partners are crucial for the successful scale-up and market introduction of CGTs, ensuring patients benefit from these groundbreaking treatments.

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View European Pharmaceutical Manufacturer article here.