We help translate your process from the lab bench to commercial-scale, by integrating appropriate manufacturing techniques as a complete ‘needle-to-needle’ system. This begins by undertaking an in-depth review, conducting a comprehensive risk assessment, and performing a cost of goods analysis to establish the commercial feasibility of the therapy production options.
Next, we identify the most suitable manufacturing system for your specific therapy and develop a strategic plan to transition to the preferred approach by considering the following factors:
- The total cost of therapy as production volumes increase
- The available commercial-scale processing technologies that can be deployed
- Short-term requirements, including clinical trials, schedule, capacity and technical issues
- Long-term GMP scale-up plans, including volumes, timing and production strategies (including the potential use of a CMO and then the technology transfer to your own facility)
The selected process technologies and automation are integrated to match your budget and operational needs as they evolve through clinical trials and into manufacture.