Cell and gene therapies are increasingly emerging as life-saving treatments for many conditions, from oncology to rare diseases. Despite many achieving regulatory approval, the industry continues to face significant commercial hurdles in producing them at scale, owing to high manufacturing costs and off-line quality control processes that can take weeks to complete. Without technical innovation to tackle these challenges, the market risks slowing down – significantly limiting patient access.
The current processes involved in cell and gene therapy manufacturing are highly complex and often largely reliant on manual handling. Mandatory and stringent quality controls result in high processing costs and an increased risk of batch failures, presenting significant challenges to scalable and efficient therapy manufacturing.
End-to-end automation and standardisation can help to streamline these processes. Achieving this relies on a deep understanding of the processes themselves and the associated sources of variation, such as each patient’s cells.
Existing measurement systems often come with high capital costs and slow turn-around times from being conducted off-line. They also often do not provide clear and easily actionable data for manufacturers to optimise their process in a cost-effective manner.
Recent progress in compact sensing technologies and AI are offering opportunities to address these manufacturing shortcomings by enabling real-time measurement and facilitating a better understanding of the link between process parameters (e.g. temperature, transduction parameters, media exchange frequency) and quality attributes (e.g. purity, potency, cell viability and cell phenotype).
