Boom time for US CDMOs: part 2

The key technology trends driving the API market cited by US CDMOs are familiar ones: high potency APIs (HPAIs), including controlled substances, and continuous manufacturing. Alcami’s most recent investment has been in HPAIs and it is just completing a $6 million build-out at its Germantown (Wisconsin, USA) API facility. The firm has dedicated two of the five GMP kilo labs to HPAIs and the target is to get to 30 ng containment, mainly through engineering controls and equipment.

Although the facility still makes tonnes of API, Millar said: “The growth and profitability is being driven by high potency. We are investing in infrastructure and technology and we have our own toxicologist on site, so when we get a process in we do a two-headed evaluation, looking at the final product but also a risk assessment for each step.”

In some cases, an intermediate is highly potent but not the final product, so Alcami will look at all the steps to see which are highest risk and which need containment. The company has also invested in infrastructure for controlled substances at the same site; it recently had its analytical registration approved by the DEA and expects its manufacturing licence to be approved shortly.

“So, yes, we have metric tonne capacity, but what we are really looking at is what our customers are going to keep in the US for manufacturing and that tends to be highly potent, controlled substances and complex chemistry,” Millar said. The first projects are due to start in September, once the ongoing investment is completed.

Millar added that Alcami is also looking at continuous flow chemistry, specifically hydrogenation. “We have capabilities in the field and it tends to be a rate-limiting aspect, so we would be interested in the right technology. We have started thinking about it and putting feelers out to equipment suppliers, customers and other CDMOs,” he said.