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Industry

SSPC provides the sector with a nationally distributed, research performing community that enables high impact, collaborative research between industry and academic partners within the life sciences sector. The Centre has a broad research capability that encompasses scientific expertise in small and large molecule drug substance and drug product manufacturing with a particular emphasis on process optimisation, data analytics and ATMPs

SSPC supports 46 industry partners:
Offering world-wide companies a unique and pioneering research proposition.

Case Study: Scale-Up Systems

The Collaborative Project:

Scale-up Systems develops the world’s leading drug substance process development software for scientists and engineers in the Pharmaceutical industry. Scale-up Systems initiated a CFD study by SSPC (Prof. Harry Van den Akker’s group) on the hydrodynamics of commonly used lab-scale reactor systems under typical operating conditions.

Predictions of mixing using traditional chemical engineering relationships become more difficult as the scale of operation decreases below a few litres.

This project completed a number of CFD simulations allowing more detailed process characterisation and will enable users of Dynochem software to make more accurate predictions when scaling-up or down.

Lead researchers:

Prof. Harry Van den Akker and Dr. Javad Zeinali at the University of Limerick.

The purpose of the project:

To investigate the hydrodynamics of commonly used lab-scale reactor systems under typical operating conditions. Predictions of mixing using traditional chemical engineering relationships become more difficult as the scale of operation decreases below a few litres. This project completed a number of computational fluid dynamic simulations allowing more detailed process characterization and will enable users of the company’s Dynochem software to make more accurate predictions when scaling-up or down as part of pharmaceutical development and manufacturing.

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Expertise:

The Van den Akker group brought expertise in CFD modelling and fluid mechanics and Scale-up Systems brought know-how of reactor vessels, including dimensions, suitable operating conditions and general behaviour as calculated using chemical engineering principles; prior knowledge of CFD and some input files for OpenFoam® software.

Results:

The output of this project has been the advancement of knowledge of small-scale chemical reactors in order to better understand mixing performance at these scales and to translate that to larger scale equipment.

This new level of understanding can potentially improve efficiencies in drug substance production within the pharmaceutical sector, especially the reduction of batch failures and increased right first time performance.

A licence to the project technology was granted to Scale-up Systems in 2020. A further collaborative research project was undertaken in October 2020. The outputs of this second project were the subject of another licence to Scale-up Systems in early 2021.

Scale-up Systems will use the simulations developed to provide users of their Dynochem software with more accurate predictions of the scalability of processes in early-stage development.

Prof. Harry Van Den Akker:

“It was a pleasure working with Scale-up Systems as it also allowed us to perform simulations of varying levels of sophistication for geometries and conditions relevant to industry and to check their mutual deviations and their respective pros and cons. The response and input from Scale-up Systems was to the point and valuable. The support by TTO was very appropriate and welcome.”

 It was a pleasure for our team (Dr Andrew Bird and Dr. Charles Gordon) to work with the Van den Akker modelling group in SSPC with support from Aisling Arthur and the University of Limerick Technical Transfer Office.

The work was conducted to the highest academic and professional standards and provides reassurance about scale-up from these very common lab set-ups. The approach of the modelling team made excellent use of state of the art facilities and automation opportunities as well as their knowledge of fluid mechanics and modelling techniques.

Joe Hannon

CEO, Scale-up Systems

Case Study: Pfizer

DeSouza Process – Pregabalin: Transformed Crystallization

A partnership between Pfizer (Ringaskiddy, Cork, Ireland) and SSPC at the University of Limerick.

The Challenge:

In 2012, Dr. Patrick Frawley started taking Lyrica (Pregabalin) for severe nerve pain associated with his spine.  He decided to use his expertise in predictive modelling, process design and fluid mechanics to reduce the cost of manufacture.  The strong working relationship between Dr. Patrick Frawley, (UL) & Pfizer facilitated easy interaction and a SFI TIDA programme application was assembled. Two postdocs in UL worked with the Pfizer team in the Process Development Centre Cork, who shared manufacturing procedures and materials. The problem statement was clear and related to process inefficiency, complexity and cost.

Project Impact:

The research has significantly impacted a manufacturing process within the pharmaceutical sector.

Project Solution:

The finalised innovative solution developed was divided into two parts.

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The Challenge:

Dr. Patrick Frawley started taking Lyrica (Pregabalin) for severe nerve pain associated with his spine.  He decided to use his expertise in predictive modelling, process design and fluid mechanics to reduce the cost of manufacture.  The strong working relationship between Dr. Patrick Frawley, (UL) & Pfizer facilitated easy interaction and a SFI TIDA programme application was assembled. Two postdocs in UL worked with the Pfizer team in the Process Development Centre Cork, who shared manufacturing procedures and materials. The problem statement was clear and related to process inefficiency, complexity and cost.

Project Impact:

The research has significantly impacted a manufacturing process within the pharmaceutical sector. This is evident through an increase in yield, improved efficiencies, and reduction in solvent use and complexity, improvements in throughput and better particle consistency. The candidate API selected for optimisation, Pregabalin known by the brand name Lyrica, was and remains one of Pfizer’s biggest multi billion euro selling APIs. Significant economic benefits will be derived from this research. This work has also built bridges and credibility between Irish plants and US corporate units through active engagement, regular meetings with Research Laboratories in the US and the exchange of key staff. Publication: Solubility of (S)-3-(Aminomethyl)-5-Methylhexanoic Acid in Pure and Binary Solvent Mixtures, J. Chem. Eng. Data, DOI: 10.1021/acs.jced.5b00736.

Project Solution:

The finalised innovative solution developed was divided into two parts.

The first part of the solution involved changing from a complex four step crystallization procedure using a modified solvent matrix to a single cool down procedure. This provided considerable benefits, in terms of time, throughput, solvent costs and Particle Size Distribution. Despite the many benefits of this approach, application of this step alone had been calculated to result in a similar yield to the current crystallisation procedure at plant scale – hence the requirement for a further step.

The second part of the solution focused on maximising yield. It is critical to maximise yield as API which is not returned from the solution represents a loss, and this can be a significant expense for the pharmaceutical manufacturer. This was realised by pressure recrystallization thus increasing the solvent boiling point and allowing for a higher solubility at the process start. It is important to note that the improvements described could be applied either individually or synergistically in combination. A lack of uniformity in particle size distribution can have consequences for downstream processes such as filtering and drying. The pressurisation approach has the advantage of preserving the benefit of a monomodal PSD. Pressure recrystallisation, as a means of improving yield, has been championed in the University of Limerick using several commercially available API’s including paracetamol. A novel test rig, developed in the University, allows for non-intrusive high temperature / high pressure measurements, which could not be obtained using the standard gravimetric approach. This platform technology is being developed further with potential commercialisation in the future. This approach is been considered for other processes being redesigned by the PDC at Pfizer.

Prof. Liam Tully, Pfizer:

“An application that has significantly impacted a manufacturing process within the pharmaceutical sector”.

An application that has significantly impacted a manufacturing process within the pharmaceutical sector.

Prof. Liam Tully

Pfizer Global Process Development Centre

Looking to engage with us?

Become an Industry Member

  • Access to a €12M research programme with world leading academic experts
  • Initiate a research project aligned with your research priorities
  • Access a talent pipeline comprising over 100 PhD graduates and post-doctorate researchers
  • Co-supervise, inform and host PhD students in an area relevant to your organisation
  • Upskill your workforce through our industry based PhD and Master’s programme
  • Benefit from high caliber training sessions
  • Be part of an international community of practice for pharmaceutical research, innovation and training

Develop a Research Project

Industry projects can be supported in a number of ways in SSPC.

  1. Companies have the option to initiate fully funded industry specific research projects and own all project IP thanks to a flexible Irish IP protocol that facilitates industry led project collaborations with Irish research performing organisations.
  2. Companies can also avail of SSPC Co-Funding (max. 50%), providing organisations with the opportunity to licence back any IP arising.

Working in partnership with the SSPC your organisation can:

  • solve key industrial challenges;
  • develop R&D capabilities;
  • attract new talent
  • co-author publications;
  • upskill staff; and
  • network with industry peers in a world leading international community of practice

Please get in touch if you’d like to know more contact our Industry Engagement Manager [email protected] or our Business Development Manager [email protected].ie

 

Industry Resources and Joint Publications

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(Bio)Pharma Ireland White Paper

The Case for a Strong EU (Bio) Pharmaceutical Manufacturing
Design and Optimization of the Single-Stage Continuous Mixed Suspension-Mixed Product Removal Crystallization of 2-Chloro- N-(4-methylphenyl)propena with APC Ltd.
low physics of planar bistable fluidic oscillator with backflow limbs with Dravam Technosciences Pvt Ltd.
Hydroxychloroquine Does Not Function as a Direct Zinc Ionophore with Janssen
Modelling the Compaction Step of a Platform Direct Compression Process with Alkermes
On the suspension of large and dense solid particles in turbulent stirred vessels with Philadelphia Mixing Solutions LLC
Identification and Pharmaceutical Characterization of a New Itraconazole Terephthalic Acid Cocrystal with Zentiva
Investigation into the Stability, Crystallization Kinetics, and Heating Rate Dependent Crystallization of Amorphous Posaconazole with MSD
Progress to Date in the Design and Operation of Continuous Crystallization Processes for Pharmaceutical Applications with Pfizer
Development of whole-cell and cell-free biosensors for the detection and differentiation of organic and inorganic forms of copper† with Alltech
The influence of poly(allylamine hydrochloride) hydrogel crosslinking density on its thermal and phosphate binding properties with Sanofi
Rational and practical considerations to guide a target product profile for patient-centric drug product development with measurable patient outcomes – A proposed roadmap with Pfizer