SPONSORED CONTENT: Launching cGMP Manufacturing for Nanoformed APIs
The innovative medicine-enabling nanotechnology company, Nanoform, discusses the construction of its first GMP manufacturing facility for the manufacture of nanonised drug particles.
This year has seen a rapid expansion of Nanoform’s manufacturing capabilities, through the construction of a state-of-the-art GMP plant. The facility will significantly increase the company’s capacity to handle potent APIs in development and also provide capability to scale up their production in a GMP environment, thus enabling nanonised materials for clinical trials and/or commercial use.
By achieving GMP Class D standards in this first facility, Nanoform will be able to handle potent APIs down to 1 µg/m3 OEL levels. This facility will also be the first in the world to manufacture GMP API particles smaller than 100nm and on occasion in the 10nm range.
Christian Jones, CCO of Nanoform, comments: “Nanoform are leading the drive towards more effective medicines by designing and producing best-in-class drug nanoparticles through our proprietary CESS® Nanonization™ technology.”
“This is the first major step for Nanoform in enabling novel R&D solutions developed by our teams to be transformed into quality GMP deliverables for our partners. It cements our position in the pharmaceutical marketplace as the ‘go-to’ experts for solubility and bioavailability enhancement and novel drug delivery applications. Further expansions are also planned to meet the significant and growing demand we see from the marketplace.
“Nanoform will deliver manufacturability assessments to provide continual and iterative process improvements for their partners. Dr David Rowe, who was appointed Head of Manufacturing this year, says: “This will ensure a best-in-class drug development process, from entry of the drug compound into the facility through to launch”
David Rowe has extensive experience proving technical leadership and strategic technical direction for both new chemical entities and commercial assets. He has deep scientific knowledge of particle size reduction platforms and the efficient commercial manufacturability of new products globally, having previously worked as the Global Particle Size Reduction Lead for GlaxoSmithKline.
Dr Rowe is now responsible for directing and implementing technical strategies and operational plans at Nanoform, which will ensure efficient commercial manufacturability of new products. The combination of a strengthened manufacturing organisation and increased capacity will enable a significant increase in the number of new drugs reaching the market.
Find out more at Nanoform.com