Research

Core Competence

The PMTC is focussed on delivering advanced technology solutions to address contemporary issues in pharmaceutical manufacturing. The core competence of the centre is currently delivering solutions in advanced rapid micro-analytical techniques; Enabling and control of continuous processing; Soft sensor modelling tools and API real time release.

Advanced rapid micro-analytical techniques

Developing new techniques to identify and test microbial contamination of all excipients, products and equipment utilised in Pharmaceutical manufacturing. This competence will deliver replacement to the current practice which is, laborious, time-consuming and costly and highlighted as a major area of concern by the sector.

Enabling and control of continuous processing

Working toward providing holistic integrated approaches to manufacturing with integrated PAT and QbD. We apply methodology of continuous processing and model predictive control to technologies used within the Irish pharmaceutical sector including current (e.g., wet granulation, compression, freeze drying, micronisation, etc.) and novel processes (e.g., hot melt extrusion (HME), powder extrusion, nanocrystals, etc). Modelling predictive control of continuous pharmaceutical processes considers each process step as a specific unit operation and takes a holistic view of the entire value stream from chemical raw materials to the finished dosage form. The aim of continuous pharmaceutical processing is to intrinsically inter link each unit operation to eliminate the requirement for corrective processing steps. Consistent product production and performance is both a key requirement and challenge to the pharmaceutical manufacturing sector.

Soft sensor modelling tools

All industries, including the pharmaceutical industry, are aware that effective use of the data that they generate is important to maintaining their competitive edge. It is important to recognise that companies operating in Ireland have varying levels of sophistication in this space. Some will prefer to outsource statistical methodology choice and development to consultants in order to concentrate on their core competencies, while other companies see having significant in house statistical and chemometrics expertise as critical to their mission and ongoing development. The PMTC has developed a strong competency in providing these solutions.

API real time release

A vital issue associated with the manufacture and analysis of solid state APIs and their formulations is the detection and quantification of chemical contaminants and alternate API polymorphs, present at low concentrations. For the Real-Time Release (RTR) of APIs one must validate the quality of the materials in terms of precisely defined contamination limits which is often accomplished by time-consuming methods like High-Performance Liquid Chromatography (HPLC) or other wet chemistry based methods. Being able to replace these traditional methods with on/in-line spectroscopic based methods will provide significant cost savings to the Irish PharmaChem sector.

Research Programme

Currently there are 6 main themes of research in PMTC. These are:

Advanced rapid micro-analytical techniques

The rapid microanlytical techniques project is a collaboration between the MiCRA (hyperlink) centre in IT Tallaght and the PMBRC (hyperlink) in WIT. The objectives of this project is to achieve selective separation and electronic detection of micro- organisms using synthetic polymer foot printing. The project is advised by a technical committee represented by Allergan, GSK, Pfizer, Helsinn, Techno-path and Janssen.

Enabling and control of continuous processing

Establish best practice through QbD and PAT initiatives to achieve a consistent quality product from a continuous dry granulation process. The project is advised by a technical committee represented by GSK, Pfizer, Merck, Helsinn, Servier, Gilead and Astellas.

Soft sensor modelling tools

The project aims to mathematically model processes using existing data to provide improved process control and robustness. The projects is advised by a technical committee represented by Pfizer, Allergan, Helsinn, Astellas, GSK and Eli Lilly.

API real time release PAT

The goal of this project is to develop a novel, and robust analytical technology platform for the rapid, in-situ, quantitative analysis of low level contaminants to enable near Real-Time-Release (RTR) during the manufacturing process. To demonstrate this a low cost flexible Liquid Chromatography (LC) platform capable of working within these constraints is being developed. The project is advised by a technical committee represented by Pfizer, Topchem, BMS, Innopharma Labs, Eli Lilly and Allergan.

Powder Processing

The project aims to gain a better understanding of the root cause of powder processing issues and define in line analytical techniques to characterise physical properties and link this to process control strategies at commercial scale. The project is advised by a technical committee represented by Pfizer, Astellas, Alkermes and Takeda.

Cleaning, validation and verification

Cleaning verification and validation has always been a time consuming and costly operation in Pharmaceutical plants. This has become even more problematic in recent years with the focus on decreased inventory thus resulting in more changeovers and more cleaning. PMTC recently initiated a new project call to address the industry wide issues associated with cleaning.

For more details please contact us.

Project Road Maps

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Publications

An Improved Process for the Preparation of Tenofovir Disoproxil Fumarate

† Department of Chemistry, Natural and Agricultural Sciences, University of Pretoria, 2 Lynnwood Road, Hatfield, 0002, Gauteng, South Africa
‡ Department of Engineering and Technology Management, University of Pretoria, Pretoria, South Africa
§ Pharmaceutical Manufacturing Technology Centre, University of Limerick, Limerick, V94 T9PX, Republic of Ireland
∥ iThemba Pharmaceuticals, Modderfontein, 1645, Gauteng South Africa
Org. Process Res. Dev., Article ASAP
DOI: 10.1021/acs.oprd.5b00364
Publication Date (Web): March 04, 2016
Copyright © 2016 American Chemical Society

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Catherine Potter, Yiwei Tian, Gavin Walker, Colin McCoy, Peter Hornsby, Conor Donnelly, David S Jones, Gavin P Andrews, A Novel Supercritical Carbon Dioxide Impregnation Technique for the Production of Amorphous Solid Drug Dispersions: A Comparison to Hot Melt Extrusion,

Molecular Pharmaceutics 03/2015;

DOI:10.1021/mp500644h, Article in press,

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Douglas, P., Albadarin, A.B., Al-Muhtaseb, A.H., Mangwandi, C., Walker, G.M.

Thermo-mechanical properties of poly ε-caprolactone/poly l-lactic acid blends: Addition of nalidixic acid and polyethylene glycol additives

(2015) Journal of the Mechanical Behavior of Biomedical Materials, 45, pp. 154-165.

DOI: 10.1016/j.jmbbm.2015.01.022

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McAuliffe, M.A.P., Omahony, G.E., Blackshields, C.A., Collins, J.A., Egan, D.P., Kiernan, L., Oneill, E., Lenihan, S., Walker, G.M., Crean, A.M.

The use of PAT and off-line methods for monitoring of roller compacted ribbon and granule properties with a view to continuous processing

(2015) Organic Process Research and Development, 19 (1), pp. 158-166.

DOI: 10.1021/op5000013

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Mangwandi, C., JiangTao, L., Albadarin, A.B., Dhenge, R.M., Walker, G.M.

High shear granulation of binary mixtures: Effect of powder composition on granule properties

(2015) Powder Technology, 270 (PB), pp. 424-434.

DOI: 10.1016/j.powtec.2014.06.021

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Mirza, Z., Liu, J., Glocheux, Y., Albadarin, A.B., Walker, G.M., Mangwandi, C. Effect of impeller design on homogeneity, size and strength of pharmaceutical granules produced by high-shear wet granulation

Particuology 2014 Article in Press

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Mangwandi, C., JiangTao, L., Albadarin, A.B., Dhenge, R.M., Walker, G.M.

High shear granulation of binary mixtures: Effect of powder composition on granule properties

(2014) Powder Technology, Article in Press.

DOI: 10.1016/j.powtec.2014.06.021

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Mangwandi, C., Albadarin, A.B., JiangTao, L., Allen, S., Walker, G.M.

Development of a high shear co-granulation process

(2014) Powder Technology, 252, pp. 33-41.

DOI: 10.1016/j.powtec.2013.10.039