SAMPA: Scale Up of an Advanced Manufacturing process to produce a Pharmaceutical product Application
In 2015, Sigmoid Pharma was awarded a 1.6 million grant from the European Commission. Sigmoid received the grant under the Horizon 2020 European Union funding for Research & Innovation programme topic; NMP-25-2014 Accelerating the update of nanotechnologies, advanced materials or advanced manufacturing and processing technologies by SMEs.
The objective of the SAMPA programme is to scale up the SmPill manufacturing process from current small scale to commercial scale. SmPill is an integrated oral drug delivery platform technology that integrates solubility, permeability and stability enhancement with targeted gastrointestinal release. SmPill manufacturing requires an advanced manufacturing process that involves novel custom made equipment, proprietary nanoemulsion-based drug formulation approaches and incorporates process analytical technologies. The proprietary SmPill drug formulation and manufacturing process will be first applied to the development and commercialisation of CyCol and AlloCol.
CyCol is a proprietary SmPill-enabled colon-targeted formulation of cyclosporine advancing into late stage clinical development for the treatment of ulcerative colitis. AlloCol is a proprietary SmPill-enabled controlled release formulation of cyclosporine that is orphan designated for the prevention and treatment of graft versus host disease.
Sigmoid is working with a number of European companies to advance the scale up of the SmPill advanced manufacturing process, including:
- a German advanced engineering and equipment manufacturing company to design, manufacture and develope customised equipment to meet Sigmoids specifications
- an Irish SME focused on chemical engineering solutions to permit incorporation of an upstream Process Analytical Technology (PAT)
- an Irish SME focused on developing and utilising PAT instruments to monitor and control downstream processing
Sigmoid has completed much of the work plan under the Grant Agreement, including the design and initial testing of the equipment. Critical Process Parameters of the manufacturing steps have been defined for transfer to larger scale processing. The in process characteristics of the SmPill minispheres for CyCol and AlloCol have been assessed. Planning for process development to support large scale processing has been completed, and an experimental stability protocol has been prepared with plans in place to initiate the first stability study related to scale up.
Sigmoid will submit an interim progress report to the European Commission in mid-2016.
This project has received funding from the European Unions Horizon 2020 research and innovation programme under grant agreement number: 666795