OBJECTIVES: Governments in many countries (e.g. UK and Canada) are investing in developing cell and gene therapy (CGT) R&D, manufacturing, and commercialisation capabilities. Associated economic incentives to stimulate local job creation is a primary driver and keeping innovation in-house is a secondary driver. The objective of this study is to analyse the strengths and weaknesses of government-sanctioned manufacturing of autologous CGTs versus traditional manufacturing models used by Biopharma.

METHODS: A detailed review of publications, government policies and investment practices was conducted to highlight existing and future plans for enabling domestic manufacturing. An evaluation of the pros and cons of domestic CGT manufacturing was also conducted.

RESULTS: Domestic manufacturing of autologous CGTs offers several advantages over traditional manufacturing models used by Biopharma. Key strengths include: Democratisation of development, localisation of supply by leveraging the use of existing healthcare infrastructure, improved logistics and flexibility in responding to local patient demand, and lower cost to the healthcare system. Major drivers are the preferential regulatory and/or reimbursement pathways for domestic products. However, there are important weaknesses that will need to be addressed to displace Biopharma manufactures. These include lack of consistency in manufacturing quality for autologous therapies globally and the infrastructure required to gather real world evidence on safety and long-term efficacy for CGT products.

CONCLUSIONS: Access to CGTs has become a staple item on the national agenda for many countries. Governments are starting to invest in large-scale manufacturing facilities, and more countries are likely to join the race. Given the different strengths on both sides, this creates an opportunity for collaboration between domestic manufacturers and Biopharma to develop a steady path forward and ensure patients have access to these transformative therapies.