The next wave of highly potent and tailored small molecule drugs poses a serious challenge to the current batch manufacturing infrastructure; frequently, oversized equipment is simply unsuitable for lower volumes. And that’s why companies such as Eli Lilly – with a number of potent cancer treatments that target small patient populations in its pipeline – are considering continuous manufacturing.
Although many groups have been able to continuously manufacture APIs, achieving cGMP and strict regulatory compliance can be challenging. In a recent study (1), Eli Lilly report the development of a multistep continuous process that produced 24 kg of prexasertib monolactate monohydrate under cGMP. Eight continuous unit operations were conducted to produce the target at roughly 3 kg per day. Kevin Cole, Principal Research Scientist at Eli Lilly and Company, tells us more.
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