What is the typical time from target to manufacturing?


As I understand the question, you are inquiring about the timeline of a novel lead therapeutic from preclinical development to initiation of the first clinical manufacturing run. If a good platform process development strategy has been established, the overall timeline won’t be significantly different from that of a fed-batch process. Specifically, in cell line development and clone selection there will be additional studies on cell line stability and robustness compared to a fed-batch program but this additional work can be conducted in parallel with other development activities thus not impacting the overall development timeline to a great extent. During cell culture process development, the duration of each run will be longer than fed-batch but the total rounds of studies and number of bioreactors can be greatly reduced given that the performance of the host cell line and media has been previously well-characterized as part of the platform development process. Therefore, the timeline of continuous process development will be comparable or perhaps slightly longer than that of a fed-batch program. Finally, once the process has been locked, the process can be directly scaled up from benchtop models to tox or clinical scale at 50 L or 200 L in most cases (or 1000 L if needed), thanks to the high batch productivity and good process robustness typical of perfusion cell culture. We’ve routinely accomplished preclinical development to GMP production on multiple projects in 18-24 months.  Programs that fit well with our platform process fall into the 18-20 month range.

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