Foster Delivery Science has added characterisation services for solid dose drugs produced using the increasingly popular manufacturing technique hot melt extrusion.
The US firm – a specialist CMO that focuses on hot-melt extrusion - has set up a lab at its facility in Putnam, Connecticut that will characterise customers’ drug-polymer candidates using a range of thermal analysis, spectroscopy and chromatography techniques.
Company managing director Tony Listro said: “In the pharmaceutical industry there are really no other contract service providers that focus only on this process for solid dose drug delivery.
“The addition of in-house characterization services allows us to accelerate time to market for our customers with rapid data-based decision making throughout the development cycle.”
Excella has become the first company worldwide to achieve SafeBridge certification for the synthesis of potent ingredients and oral solid dosage (OSD) forms after the US manufacturing standards firm granted OKed it for API production
The certification – which applies to Excella’s facility in Feucht, Southern Germany and covers the production and handling of potent APIs – follows a detailed review of manufacturing operations, containment procedures and controls that took place late last year.
The plant is one of only nine worldwide to have met SafeBridge’s criteria for potent ingredient and Excella is only 11th manufacturer to have been grated such accreditation since the programme was launched in 1999
In other manufacturing news New Jersey-based contractor Catalent has completed the expansion of its over-the-counter (OTC) dosage form facility in Italy.
The plant in Aprilia, central Italy, produces a range of solubility enhancing products, including Catalent’s Vegicaps technology. The firm did not respond to a request for additional information ahead of publication.
And finally for this week, Swiss CMO RohnerChem has expanded its API process development capabilities through a partnership with German enzyme production technology specialist evocatal.
The aim is to provide a ‘cost competitive’ service process development for active pharmaceutical ingredients (API) synthesis that can be rapidly scaled-up and – according to the firms – reduce commercialisation timelines.
The non- exclusive partnership – financial terms of which have not been disclosed – is similar to the deal RohnerChem agreed with analytical and solid-state chemistry services firm Solvias in October last year.