The new plant in Kinsale, County Cork is expected to open early next year and will become Lilly’s worldwide centre of excellence for continuous manufacturing of Active Pharmaceutical Ingredients (API) through this investment.
“The team is highly motivated to undertake this project as it offers a significant new opportunity for the site,” said Chris Langan, general manager at the site. “The company is amongst the industry leaders in the development of this technology, and it is an exciting project for everyone involved here at the site.”
This is the latest investment at Kinsale, hot off the back of Lilly’s new commercial scale biologics facility, a 240,000 sq ft plant which opened last year at a cost of €330m.
The pharmaceutical industry has been slow to adopt to continuous manufacturing as companies remain averse to switching to new processes and equipment, while lacking the talent and clear regulatory guidelines to do so.
But over the past few years, industry has taken a number of strides in shifting to more continuous methods for both small and large molecule.
A ten-year collaboration between Rutgers University and J&J’s Janssen to implement has produced a continuous manufacturing line at the pharma firm’s facility in Puerto Rico, while GSK, Pfizer and Novartis have also invested in developing such technologies.
And in a White House report on the state of US manufacturing published this week by the Subcommittee for Advanced Manufacturing of the National Science and Technology Council, continuous manufacturing was high-lighted as a way of improving “the agility, flexibility, and robustness in the manufacture of pharmaceuticals.”
However, while the report says such technology is promising at the laboratory scale, it adds the technologies and equipment enabling continuous manufacturing at the commercial scale are not widely available or accessible.
“Consequently, continuous manufacturing technology is currently in need of further interest and resources from industry, government, and regulatory authorities to translate proofs-of-concept to widespread commercial adoption.”
The report also notes the US Food and Drug Administration (FDA) will be essential in bringing about the shift from batch to continuous manufacturing, “using scientific and data-driven methodologies to facilitate future approvals, thereby encouraging commercial adoption of continuous manufacturing.”