Molecular Profiles has invested in hot melt extrusion (HME) and nano milling capabilities citing client demand for improving the bioavailablity of drugs.
The investment sees the contract development and manufacturing organisation (CDMO) – acquired by Columbia Laboratories last September - adding a variety of platforms to its recently approved £9m ($15m) clinical manufacturing plant in Nottingham.
“We already had an infrastructure in this enabling technologies area that has been developed over the years but this recent investment of hundreds of thousands of pounds was primarily in two key areas; HME and our nano milling capabilities,” Commercial Director Claire Madden-Smith told Outsourcing-Pharma.com.
Several key clients “helped inform the equipment selection to ensure it’s in line with current and future market demands,” she continued, but added the investment was due to general demand from the industry.
“Currently there are many challenges in creating effective and bioavailable drug products and HME is one of the rafts of enabling technologies that can provide a development route to clinic.”
Before the expansion Molecular Profiles was “doing all the ‘understanding’ elements with clients but could not GMP manufacture,” she said, but now the firm has the capability to “take clients through the whole process from start to finish.”
The company is the latest CDMO to look to HME capabilities, joining a list that includes Ashland , Patheon, Catalent and Bend (now owned by Capsugel) who have all invested in such services in the last few years.
“With HME generally, we are trying to achieve a molecular dispersion of a drug in a polymer carrier,” Madden-Smith said. “Inherently, this is a metastable state, which means the product can suffer from stability issues.
“Those skilled in the art of HME can apply knowledge to help overcome such challenges for drug development companies.”