SSPC Industry Impact of the Year has been awarded to a collaboration between Alkermes Athlone, SSPC, the SFI Research Centre for Pharmaceuticals team at the School of Pharmacy, University College Cork, and Pharmaceutical Manufacturing Technology Centre (PMTC) at the University of Limerick.
This industry-led project was devised by Stephen Sheehan, Principal Engineer and Claire O’Reilly, Senior Process Development Engineer at Alkermes, Athlone, who developed the project with Prof. Abina Crean and Dr David Egan. The project was funded through the Enterprise Ireland Innovation Partnership programme.
Welcoming the group to the Alkermes plant in Athone, Mark Tawa, Vice President, Pharmaceutical Development, Alkermes, said: “Alkermes is delighted to be involved in a project that demonstrates an important collaboration between industry and academia capable of producing a practical and tangible business outcome. Such a collaboration serves to strengthen both parties and provides an example for future opportunities.”
The project established a platform approach to inform the design of direct compression tablet formulations for future commercial products. A platform approach is the application of common processes that can be used to streamline development activities. The use of a platform approach during product development has the potential to decrease development time and cost, decrease time to market, and simplify scale up and process transfer.
To date, models and knowledge developed during the project have been shared with Alkermes sites in Ireland and the US. Models are being used to inform early-stage blend formulation development to maximise commercial production rates. The models can also be used during new product development, to streamline scale up/tech transfer from lab scale to commercial tablet presses.
Stephen Sheehan, Principal Engineer, Alkermes Athlone said: “The collaborative research project that SSPC carried out with Alkermes has given us new capabilities that inform and streamline early development activities and enable us to predict future commercial performance. We are in the process of sharing this learning across Alkermes in Ireland and the US, and plan to integrate and apply the learnings into our commercial process.”
Prof. Abina Crean, added: “It’s fantastic to see our ongoing engagement with Alkermes continue to go from strength to strength given the importance of this industry to the Irish economy. I am also delighted that this project is being acknowledged by SSPC for its impact, which has been achieved through the provision of knowledge exchange between highly trained scientists and excellent research outputs that directly affect the process R&D capabilities of pharmaceutical companies in Ireland.”
All researchers recruited for the project are now working in the Irish Pharmaceutical sector; Pfizer, Newbridge and Alexion Pharmaceuticals. For example, Dr Raghu Peddapatla was recruited by Alkermes, Athlone as a Lead Process Development Engineer after the project for two years and is currently working as a Process Excellence Lead at Pfizer, Newbridge. In addition to technical experience, during this project researchers developed transferable skills, mentorship from Alkermes scientists and engineers and broadened their professional network.
The €500 prize money for the award will be donated to Alkermes sponsored charity (MS Ireland).
SSPC’s expertise spans over nine Higher Education Institutions nationwide and aims to strategically shift Ireland into the higher-value, reward area of pharmaceutical R&D, enhancing the competitiveness of the industry, with the ultimate goal of enabling new employment and economic growth.
The modelling approaches employed have been published in two peer-reviewed research publications:
Peddapatla, R.V.G.; Sheridan, G.; Slevin, C.; Swaminathan, S.; Browning, I.; Reilly, C.O.; Worku, Z.A.; Egan, D.; Sheehan, S.; Crean, A.M. Process Model Approach to Predict Tablet Weight Variability for Direct Compression Formulations at Pilot and Production Scale. Pharmaceutics 2021, 13, 1–14 (https://doi.org/10.3390/pharmaceutics13071033)
Raghu V. G. Peddapatla, Conor Slevin, Gerard Sheridan, Caoimhe Beirne , Shrikant Swaminathan, Ivan Browning , Clare O’Reilly , Zelalem A. Worku, David Egan, Stephen Sheehan and Abina M. Crean. Modelling the Compaction Step of a Platform Direct Compression Process. Pharmaceutics 2022, 14(4) (https://doi.org/10.3390/pharmaceutics14040695)
Pictured from left to right: Paul Hurley, (Director, Process Development, Alkermes), Mairead Fogarty, (Executive Director, Process Development, Alkermes), Raghu Peddapatla, (Process Excellence Lead, Pfizer), Ger Sheridan (Operation Support Specialist, Alexion Pharmaceuticals), Stephen Sheehan, (Principal Engineer, External Operations, Alkermes), Abina Crean, University College Cork, Conor Slevin, (Manufacturing Engineer III, Alexion Pharmaceuticals), Aisling Arthur, SSPC Industry Relations Manager and Mark Tawa, (Vice President, Pharmaceutical Development, Alkermes).