Centres & Group – SSPC2018-09-10T15:32:44+00:00

SSPC

The Synthesis and Solid State Pharmaceutical Centre (SSPC), a Global Hub of Pharmaceutical Process Innovation and Advanced Manufacturing, funded by Science Foundation Ireland and industry, is a unique collaboration between 24 industry partners, 9 research performing organisations and 12 international academic collaborators. SSPC is hosted in Bernal Institute, University of Limerick.

The SSPC transcends company and academic boundaries and is the largest research collaboration in Ireland, and one of the largest globally, within the pharmaceutical area. The role of the SSPC is to link experienced scientists and engineers in academia and the pharmaceutical industry, to address critical research challenges.

The SSPC leads the way for next generation drug manufacture and spans the entire pharmaceutical production chain from synthesis of the molecule, to the isolation of the material, and the formulation of the medicine. The aim of the SSPC is to deliver industry relevant solutions, which result in job growth and retention within the pharmaceutical industry in Ireland.

The research programme spans the entire pharmaceutical production chain from synthesis of the molecule, to the isolation of the material, and the formulation of the medicine.

The SSPC research programme is organised into three interconnecting strands, which actively reflect the three distinct steps in the manufacture of modern medicines.

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Projects

Research Strands (the term “Strands” applies to SSPC only and replaces the term projects)

Strand 1 – New Frontiers in Pharmaceutical Synthesis

The focus of the New Frontiers in Pharmaceutical Synthesis strand is on enantioselective and efficient synthetic routes and processes. Major themes include:

  • New catalysts and systems for cleaner production with excellent selectivity in asymmetric synthesis, elimination of hazardous reagents and operation in benign conditions
  • Innovative process technologies operating in flow conditions and where appropriate achieving multiple transformation steps in a single reactor
  • New chemical methods for the efficient removal of impurities and side products

These themes are linked to Strand 2 by the delivery of a very high level of impurity profiling fully cognisant that every aspect of crystallisation can be severely affected by the presence of impurities, side products and solvents at ppm or ppb levels, which are usually carried over from previous synthesis steps.

Strand 2 – Crystal Growth and Design

The focus of Strand 2: Crystal Growth and Design is on science and process engineering underpinning the crystallisation of complex organic molecules with conformational flexibility and a multitude of functional groups. Impurities and solvent selection are central to this strand. Major themes include:

  • Study of the underlying molecular interactions in supersaturated solutions and at interfaces
  • Understanding the mechanisms that control product crystal properties such as crystal structure, purity, shape and size
  • Exploiting these mechanisms to tailor and control crystal properties, to scale up and scale down processes, to develop model based control for improved product quality in traditional batch crystallisations as well as in emerging technologies like continuous processing, cocrystallisation, nanocrystallisation and crystallisation into excipient matrices

Strand 3 – Drug Product Formulation and Manufacture

The Drug Product Formulation and Manufacture strand focuses on bringing stronger scientific and process engineering principles and knowledge into the domain of Solid State Pharmaceutics, which up to now has essentially been empiric. This improved approach is demanded by the Quality by Design (QbD) knowledge based approach to develop new products and formulations. Major themes include:

  • Understanding the nature and strength of interactions between APIs and excipients
  • Identification of currently unknown critical attributes in APIs and excipients that lead to failures during formulation
  • Development of new materials and technologies for the generation and stabilisation of the amorphous state, which is one approach to realising the potential of BSC Class II poorly soluble drugs