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molecule<br />
material<br />
medicine
synthesis<br />
of the molecule<br />
developing more environmentally<br />
sustainable methods for drug<br />
manufacturing<br />
molecule<br />
isolation<br />
of the material<br />
increasing the range of medicines<br />
available to the public<br />
material<br />
formulation<br />
of the medicine<br />
reducing drug manufacturing costs<br />
medicine
CONTENTS<br />
P2<br />
NEXT<br />
GENERATION<br />
DRUG<br />
MANUFACTURE<br />
P6<br />
UNPARALLELED<br />
INDUSTRY<br />
ENGAGEMENT<br />
P10<br />
SCIENTIFIC<br />
EXCELLENCE<br />
P18<br />
WORLD<br />
LEADING<br />
INVESTIGATORS<br />
P24<br />
FUNDING &<br />
PARTNERSHIP<br />
P26<br />
DEVELOPING<br />
NEXT<br />
GENERATION<br />
SCIENTISTS
OUR MISSION<br />
TO POSITION IRELAND AS A GLOBAL<br />
HUB FOR PROCESS INNOVATION<br />
AND ADVANCED MANUFACTURING<br />
IN THE PHARMACEUTICAL INDUSTRY
SSPC IN NUMBERS<br />
42<br />
MILLION<br />
INVESTMENT<br />
34<br />
POST-DOCTORAL<br />
RESEARCHERS<br />
20<br />
RESEARCH<br />
PROJECTS<br />
38<br />
INVESTIGATORS<br />
60<br />
PhD<br />
CANDIDATES<br />
43<br />
RESEARCH<br />
PERFORMING<br />
ORGANISATIONS<br />
& INDUSTRY<br />
PARTNERS<br />
www.<strong>sspc</strong>.ie
SSPC<br />
GLOBAL<br />
PARTNERSHIPS<br />
Canada<br />
TORONTO<br />
IRELAND<br />
United States<br />
CALIFORNIA<br />
FLORIDA<br />
ILLINOIS<br />
INDIANA<br />
MASSACHUSETTS<br />
NEW JERSEY<br />
NEW YORK<br />
TEXAS<br />
TO POSITION IRELAND AS A GLOBAL HUB FOR PROCESS
Europe<br />
BELGIUM<br />
FRANCE<br />
ITALY<br />
NETHERLANDS<br />
SWITZERLAND<br />
UK<br />
Asia<br />
CHINA<br />
SINGAPORE<br />
INNOVATION AND ADVANCED MANUFACTURING IN THE PHARMACEUTICAL INDUSTRY
1<br />
NEXT GENERATION<br />
DRUG MANUFACTURE
Launched in July 2013, the SSPC research programme leads the way for next generation<br />
drug manufacture. The SSPC is the largest research collaboration in Ireland, and one of the<br />
<br />
Science Foundation Ireland and industry investment of €42 million. The SSPC builds upon the<br />
success and foundations of the Solid State Pharmaceutical Cluster (2007-2013), which was<br />
funded by Science Foundation Ireland’s Strategic Research Cluster programme. The Solid<br />
State Pharmaceutical Cluster research programme focused exclusively upon the crystallisation<br />
stage of the manufacturing process. Within the pharmaceutical industry, this stage is the<br />
<br />
understanding of the science and engineering challenges at this stage of the process.<br />
Building upon this success, the SSPC research programme now spans the entire<br />
pharmaceutical production chain from synthesis of the molecule, to the isolation of the<br />
material, to the formulation of the medicine. SSPC research focuses upon developing more<br />
environmentally sustainable methods for drug manufacturing; increasing the range of<br />
medicines available to the public; and reducing drug manufacturing costs. The SSPC aims<br />
to deliver industry relevant solutions, which result in job growth and retention within the<br />
pharmaceutical industry in Ireland.<br />
3
The SSPC’s inclusive, equitable and collaborative<br />
model between our 22 industry partners, 9<br />
research performing organisations and 12<br />
international academic collaborators, successfully<br />
<br />
both academia and the pharmaceutical industry,<br />
to address critical research challenges through<br />
the SSPC research programme. This collaborative<br />
model aims to build a strong pharmaceutical<br />
community and a pharma-friendly environment in<br />
<br />
and future success.<br />
DEVELOPING<br />
more<br />
environmentally<br />
sustainable<br />
methods for drug<br />
manufacture<br />
Building upon our strong foundations, along with<br />
our successful collaborative model to attract<br />
new global industry and academic partners, the<br />
SSPC leads the way for next generation drug<br />
manufacture.<br />
Professor Kieran Hodnett<br />
<br />
INCREASING<br />
the range of<br />
medicines available<br />
to the public<br />
kieran.hodnett@ul.ie<br />
REDUCING<br />
drug<br />
manufacturing<br />
costs<br />
4
“<br />
The SSPC aims to deliver<br />
industry relevant solutions,<br />
which result in job growth<br />
and retention within the<br />
pharmaceutical industry<br />
in Ireland.<br />
”
2<br />
UNPARALLELED<br />
INDUSTRY<br />
ENGAGEMENT
Since 2012, the scale of the SSPC has<br />
increased to over three fold its original size,<br />
and is now the largest research collaboration<br />
in Ireland, and one of the largest globally,<br />
within the pharmaceutical area.<br />
The SSPC is transforming the landscape for<br />
the multinational pharma sector in Ireland.<br />
Prior to the SSPC, Ireland was perceived as<br />
a predominately manufacturing jurisdiction.<br />
As a result of the SSPC this has changed.<br />
The SSPC’s ability to facilitate multi-company<br />
projects within the precompetitive space as<br />
<br />
community has led to a paradigm shift for the<br />
sector in Ireland. Sites in Ireland now deliver<br />
a greater value proposition to corporate. Irish<br />
sites are no longer viewed as an exporter<br />
of challenges to corporate; moreover an<br />
importer of challenges from global sister sites<br />
and an exporter of cutting edge solutions<br />
<br />
engineering rigour.<br />
research services globally. As a result of the<br />
<br />
<br />
they could not have before.<br />
The SSPC prides itself upon its inclusive,<br />
equitable and collaborative model between<br />
our 22 industry partners, 9 research<br />
performing organisations and 12 international<br />
academic collaborators.<br />
Jon O’Halloran<br />
SSPC General Manager<br />
jon.ohalloran@ul.ie<br />
In the SME space the SSPC has also delivered.<br />
In 2011, the Applied Process Company<br />
(APC), a current SSPC industry partner, was<br />
established by Principal Investigator Professor<br />
Brian Glennon and Post-Doctoral Researcher,<br />
<br />
APC provides contract pharmaceutical<br />
7
Optical micrograph<br />
<br />
carbamazepine<br />
crystalline polymorphs<br />
produced from<br />
methanol using<br />
supercritical CO 2<br />
BY DR LUIS PADRELA, SSPC
BUILDING A STRONG PHARMACEUTICAL COMMUNITY AND<br />
A IN IRELAND<br />
Research Performing Organisations<br />
Industry Partners<br />
International Academic Collaborators<br />
9
3<br />
SCIENTIFIC<br />
EXCELLENCE
synthesis<br />
“ Bold, Ambitious,<br />
Wide Ranging and<br />
Highly Innovative...<br />
EXTERNAL REVIEW OF<br />
SSPC RESEARCH PROGRAMME<br />
”<br />
molecule<br />
<br />
<br />
<br />
<br />
<br />
The SSPC research programme spans the entire pharmaceutical<br />
production chain from synthesis of the molecule, to the isolation of<br />
the material, to the formulation of the medicine. The SSPC research<br />
programme focuses upon developing more environmentally<br />
sustainable methods for drug manufacture; increasing the<br />
range of medicines available to the public; and reducing drug<br />
manufacturing costs. The overarching objective is to better<br />
understand mechanisms, control processes and predict outcomes<br />
<br />
medicines. The SSPC research programme is organised into three<br />
<br />
steps in the manufacture of modern medicines.<br />
STRAND 1<br />
<br />
developing more environmentally sustainable<br />
methods for drug manufacturing<br />
isolation<br />
material<br />
STRAND 2<br />
<br />
increasing the range of medicines available to the<br />
public<br />
rmulation<br />
medicine<br />
STRAND 3<br />
<br />
reducing drug manufacturing costs<br />
11
In total, the SSPC supports 20 state of the art research projects.<br />
<br />
with economic and societal impact in Ireland. To achieve these outputs the SSPC research<br />
programme is divided into platform research projects and targeted research projects.<br />
Platform Research<br />
The SSPC research programme<br />
supports nine platform projects,<br />
which are targeted towards the<br />
<br />
<br />
of the area and aimed at achieving<br />
<br />
Targeted Projects<br />
The SSPC supports 9 targeted projects, which<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
place. The programme has been designed to pay<br />
particular attention to how attributes from each<br />
strand can impact upon each of the other strands.<br />
Optical micrograph<br />
image showing a Form<br />
II piracetam crystal<br />
undergoing a polymorphic<br />
transformation to a more<br />
stable Form III crystal in<br />
methanol at 25°C<br />
BY DR ANTHONY MAHER, SSPC,<br />
WINNER OF SFI<br />
RESEARCH IMAGE OF THE YEAR<br />
COMPETITION 2014.<br />
12
DEVELOPING MORE ENVIRONMENTALLY<br />
SUSTAINABLE METHODS FOR DRUG MANUFACTURE<br />
<br />
<br />
processes.<br />
<br />
<br />
asymmetric synthesis, elimination of hazardous reagents and operation in benign<br />
conditions.<br />
<br />
<br />
<br />
achieving multiple transformation steps in a single reactor.<br />
<br />
INCREASING THE RANGE OF<br />
MEDICINES AVAILABLE TO THE PUBLIC<br />
<br />
The focus of Strand 2 research is on science and process engineering underpinning the<br />
<br />
functional groups. Impurities and solvent selection are central to this strand.<br />
<br />
<br />
interfaces.<br />
<br />
crystal structure, purity, shape and size.<br />
<br />
<br />
<br />
scale down processes; and to develop model-based control for improved product<br />
quality in traditional batch crystallisations as well as in emerging technologies<br />
<br />
into excipient matrices.<br />
13
REDUCING DRUG<br />
MANUFACTURING COSTS<br />
<br />
<br />
<br />
has essentially been empiric. This improved approach is demanded by the Quality by<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
to failures during formulation.<br />
<br />
stabilisation of the amorphous state, which is one approach to realising the<br />
potential of BSC Class II poorly soluble drugs.<br />
14
Butyl paraben<br />
crystals grown from<br />
acetonitrile solution<br />
BY DR LIJUN JIA, SSPC
CUTTING EDGE BIOPHARMACEUTICAL RESEARCH<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
research collaboration.<br />
This collaboration received €1.05m in funding from the Department of Jobs, Innovation and<br />
<br />
with €450,000 in cash contributions from industry partners.<br />
The manufacturing process of biotherapeutic drugs is complex and costly, with problems<br />
<br />
of these therapeutics. As a result of this Advanced Biopharmaceutical Technologies<br />
<br />
<br />
<br />
intellectual property for Irish universities and gains commercial advantage for Irish-based<br />
biopharma companies.<br />
16
“<br />
This research generates<br />
<br />
property for Irish<br />
universities and gains<br />
commercial advantage<br />
for Irish-based<br />
biopharma companies.<br />
”
4<br />
WORLD LEADING<br />
INVESTIGATORS
SSPC SCIENTIFIC DIRECTOR<br />
<br />
Prof. Hodnett is the former Dean of the Faculty of Science<br />
<br />
having previously served as Head of the Department of<br />
Chemical and Environmental Sciences (1995-1998) and<br />
Director of the Materials and Surface Science Institute<br />
(1999-2003). Prof. Hodnett played a lead role in the<br />
<br />
foundations for the Solid State Pharmaceutical Cluster (2007-2013). Prof. Hodnett has published<br />
over 120 papers in refereed journals, which have over 2800 ISI citations, and has supervised 30<br />
PhD students to completion. Prof. Hodnett’s current research interests are in the polymorphism<br />
in pharmaceutical compounds and active pharmaceutical crystallisation into excipient matrices.<br />
Professor Anita Maguire<br />
<br />
PRINCIPAL INVESTIGATOR<br />
<br />
<br />
undergraduate and postgraduate<br />
<br />
<br />
1985, Ph.D. 1989). Following<br />
<br />
<br />
<br />
returned to the Department of<br />
<br />
as a College Lecturer, then as<br />
Associate Professor in Organic<br />
Chemistry in 2002. In 2004,<br />
Prof. Maguire was appointed to<br />
the newly-established Chair of<br />
Pharmaceutical Chemistry, jointly<br />
in the Department of Chemistry<br />
and the School of Pharmacy,<br />
and has played a leading role in<br />
development of the School of<br />
Pharmacy in recent years. Since<br />
<br />
Maguire has played a strategic<br />
role in the development of<br />
teaching and learning, including<br />
the introduction of Medicinal<br />
and Pharmaceutical Chemistry at<br />
<br />
time. Over the past 23 years, Prof.<br />
Maguire has led an active research<br />
team focusing on synthetic organic<br />
and pharmaceutical chemistry,<br />
which interacts extensively<br />
with the pharmaceutical sector<br />
in Ireland and internationally.<br />
Prof. Maguire is committed to<br />
postgraduate education, ensuring<br />
<br />
required to underpin their future<br />
<br />
students have graduated from her<br />
research team since 1997, most<br />
of whom have developed careers<br />
within the pharmaceutical industry<br />
both in Ireland and internationally.<br />
Prof. Maguire was appointed as<br />
Vice President for Research and<br />
Innovation in January 2011.<br />
19
Professor Pat Guiry<br />
<br />
INVESTIGATOR<br />
<br />
Prof. Pat Guiry is a Professor of Synthetic Organic<br />
<br />
<br />
College Dublin. In 2013 Prof. Guiry was elected as a<br />
Member of the Royal Irish Academy and in 2014, Prof.<br />
Guiry was appointed Royal Irish Academy Vice-Chair, Physical, Chemical and Mathematical<br />
Sciences and was awarded the Boyle-Higgins Medal by the Institute of Chemistry of Ireland.<br />
Prof. Guiry’s research specialises in synthetic organic chemistry, with interests in both the<br />
development of asymmetric synthetic methodology through the application of new chiral<br />
ligands in homogeneous metal-catalysed transformations and in the total synthesis of<br />
compounds of biological interest.<br />
Professor Åke C Rasmuson<br />
<br />
<br />
Prof. Rasmuson is a Professor of Chemical Engineering and Industrial<br />
<br />
MSc and a PhD in Chemical Engineering from the Royal Institute of<br />
<br />
<br />
<br />
processes including: fundamentals of solubility, nucleation, growth and<br />
agglomeration; experimental determination of solution thermodynamics<br />
<br />
<br />
processes; and batch crystallization process design. In addition, Prof.<br />
Rasmuson has experience of hydrodynamics and mixing in agitated<br />
<br />
and recovery of rare earth elements from mineral waste and spent car<br />
batteries. Prof. Rasmuson has been the adviser of 23 PhD programs, 23<br />
Licentiate theses and approximately 70 MSc theses.<br />
The research group at present<br />
has six postdoctoral researchers<br />
and six PhD students. Prof.<br />
Rasmuson has published 112<br />
<br />
presented 54 conference papers<br />
and coauthored 30 reports for<br />
industrial cooperation projects.<br />
20
Professor Brian Glennon<br />
<br />
<br />
Prof. Glennon is a Professor of Chemical and Bioprocess Engineering<br />
<br />
Process Engineering Research Group. The main research interests of<br />
the group are in the development and application of measurement,<br />
modelling and control strategies for the design and optimization of<br />
pharmaceutical processes. Prof. Glennon is co-founder of APC Ltd.,<br />
<br />
<br />
<br />
Professor Anne Marie Healy<br />
<br />
<br />
Prof. Healy is Professor in Pharmaceutics and Pharmaceutical<br />
Technology in the School of Pharmacy and Pharmaceutical Sciences,<br />
Trinity College Dublin (TCD) and is currently Head of School. Prof.<br />
Healy is a registered pharmacist; she holds a B.Sc. in Pharmacy and a<br />
Ph.D. in Pharmaceutics, both from TCD. Prof. Healy joined the School<br />
of Pharmacy, TCD in 1992 as a Lecturer in Pharmaceutics. In 2010, Prof.<br />
Healy was elected Fellow of Trinity College. Prof. Healy has over 60<br />
peer reviewed publications and has given over 100 presentations at<br />
national and international conferences. Prof. Healy’s research interests<br />
include pharmaceutical material science, amorphous forms, formulating<br />
poorly soluble drugs and pulmonary drug delivery.<br />
21
of Pharmaceutical Powder Engineering at the<br />
<br />
is also a Visiting Research Professor of Chemical<br />
<br />
<br />
technology, granulation processes and materials<br />
<br />
130 international journal papers (>2500 citations,<br />
h-index 26) on various aspects of chemical and<br />
process engineering and is Associate Editor of<br />
Chemical Engineering Journal and Chemical<br />
<br />
been awarded two Royal Academy of Engineering<br />
<br />
2002 and the Leverhulme Trust Senior Research<br />
Fellowship in 2009.<br />
<br />
<br />
Professor Martin Albrecht martin.albrecht@ucd.ie<br />
Niall.barron@dcu.ie<br />
Dr Jonathan Bones Jonathan.bones@nibrt.ie<br />
Colin.clarke@nibrt.ie<br />
Professor Martin Clynes Martin.clynes@dcu.ie<br />
Professor Stephen Connon Trinity College Dublin connons@tcd.ie<br />
Dr Abina Crean a.crean@ucc.ie<br />
22
Professor Gavin Davey Trinity College Dublin gdavey@tcd.ie<br />
Professor Alan Dobson a.dobson@ucc.ie<br />
Dr Andrea Erxleben andrea.erxleben@nuigalway.ie<br />
patrick.frawley@ul.ie<br />
nick.gathergood@dcu.ie<br />
Professor Declan Gilheany declan.gilheany@ucd.ie<br />
Dr Jerrard Hayes Trinity College Dublin jehayes@tcd.ie<br />
Dr Clement L. Higginbotham Athlone Institute of Technology chigginbotham@ait.ie<br />
Dr Sarah Hudson sarah.husdson@ul.ie<br />
Dr Simon E. Lawrence s.lawrence@ucc.ie<br />
Professor Edmond Magner edmond.magner@ul.ie<br />
Dr Paula Meleady Paula.meleady@dcu.ie<br />
Dr Andrew McDonald Trinity College Dublin amcdonald@tcd.ie<br />
g.mcglacken@ucc.ie<br />
Niaobh.mcloughlin@nibrt.ie<br />
Dr Peter McLoughlin Waterford Institute of Technology pmcloughlin@wit.ie<br />
Dr John Milne John.milne@nibrt.ie<br />
Trinity College Dublin Mok1@tcd.ie<br />
Dr Humphrey Moynihan h.moynihan@ucc.ie<br />
Professor Fergal O’Gara f.ogara@ucc.ie<br />
Dr Francesca Paradisi francesca.paradisi@ucd.ie<br />
Dr Kevin M. Ryan kevin.m.ryan@ul.ie<br />
Dr Alan Ryder alan.ryder@nuigalway.ie<br />
Dr Lidia Tajber Trinity College Dublin lidia.tajber@tcd.ie<br />
23
5<br />
FUNDING &<br />
PARTNERSHIP
THE SSPC IS DEDICATED TO OBTAINING<br />
EXTERNAL RESEARCH FUNDING<br />
INTERNATIONAL LEADING CENTRE OF EXCELLENCE<br />
The SSPC aims to be an internationally leading centre of excellence in synthesis<br />
and solid state pharmaceuticals. Acquiring funding and fostering collaboration with<br />
other leading international academics and centres is critical to achieving this aim. The<br />
<br />
<br />
winning competitive funding.<br />
FORMAL INTERNATIONAL COLLABORATORS<br />
The SSPC team already has an extensive international collaboration portfolio. The SSPC<br />
builds on and enhances the level of strategic international collaboration to deliver the<br />
<br />
<br />
FUNDING BIDS<br />
<br />
of the submission now involves project management experience. The SSPC has a<br />
dedicated Funding Project Manager to support researchers both in the preparation of<br />
<br />
bids involving multiple partners.<br />
<br />
<br />
and innovation programme to date; one of the biggest publicly funded worldwide<br />
<br />
<br />
Science, Industrial Leadership and Societal Challenges. The SSPC has a dedicated team<br />
responsible for supporting both national and international funding opportunities through<br />
the coordination of proposals, facilitating partner searches and navigating the myriad of<br />
open and forthcoming calls.<br />
25
6<br />
DEVELOPING<br />
NEXT GENERATION<br />
SCIENTISTS
EDUCATION<br />
The SSPC supports 60 PhD candidates. The SSPC structured PhD programme<br />
incorporates both structured and traditional research elements. The structured<br />
<br />
<br />
<br />
<br />
<br />
doctoral supervisory team. As employability is at the core of the student<br />
<br />
TRAINING<br />
The SSPC training programme is developed<br />
<br />
company training programmes that were<br />
established under the auspices of the<br />
Solid State Pharmaceutical Cluster (2007-<br />
2013). The SSPC training programme<br />
<br />
opportunities within the pharmaceutical<br />
area for SSPC partners.<br />
OUTREACH<br />
<br />
is aligned with Science Foundation<br />
Ireland’s overall outreach and public<br />
engagement strategy for research centres.<br />
The programme engages with, and<br />
communicates SSPC research to, pupils,<br />
parents, teachers and the general public.<br />
Outreach programmes are based upon<br />
teacher and scientist informed curriculum<br />
materials, which develop cutting edge<br />
activities suitable and appropriate to pupils<br />
<br />
school system.<br />
28
CONTACT US<br />
www.<strong>sspc</strong>.ie/contact_<strong>sspc</strong>
www.<strong>sspc</strong>.ie