CML aims to be west’s biggest API maker with new plant
The new facility, which will be officially opened next week, is part of CML’s bid to be the leading western supplier of active pharmaceutical ingredients (API) and intermediates to the pharma and biotech industries.
While Asia looks set to dominate the sector for the time being, both as a result of lower production costs and available capacity, high profile scandals with APIs sourced in the region have raised questions about manufacturing standards.
As a result producers in Europe and the US have begun to claw back some of the ground lost Asian manufacturers, meaning that completion of CML’s new plant could be very well timed indeed.
Even if CML fails to achieve its loft ambitions, the facility should still boost CML customer base according to CEO Michael Major.
He said that: “Without this site we would never be considered for large scale commercial manufacturing,” explaining that, in the past, the firm had lost out to rivals with larger manufacturing capacity, despite the innovative processes its chemists developed.
These thoughts were echoed by company CBO Brian Scanlan who said that: “In the past we have had to…divest opportunities to larger manufacturers due to a lack of capacity.
“Now we have the horsepower to take our clients new molecules from concept to full commercialization,” adding that “with all the hype surrounding drug safety and quality from offshore suppliers CML’s model has shown that US-based manufacturing is still alive and well.”
Economies of large-scale
The facility features six good manufacturing practice (GMP) quality production suites that can make multi-ton quantities of both APIs and pharmaceutical intermediates.
Overall output capacity is 18,000 gallons although CML capacity can be increase by another 30,000 gallons for particularly large manufacturing projects.
CML highlighted the plant’s thermal oxidizer and reaction tank that, it claimed, offer both US Environmentally Protection Agency (EPA) air quality standards and optimized solvent usage.
The firm also explained that its will be to funnel projects from its three kilograms-scale development centres to Germantown when industrial production is required.
