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Institutes of Technology Ireland
Research & Innovation

Identification of Impurities within an Anti-Cancer Drug

EirGen Pharma is a pharmaceutical company based in Waterford, Ireland. Using its purpose built high-containment facility, EirGen Pharma specialises in the development, manufacture and registration of high potency cancer therapy products for global pharmaceutical markets. EirGen Pharma has recently developed Eir-010, a drug treatment for breast cancer, the leading cause of cancer-related deaths among Irish women.

The Pharmaceutical and Molecular Biotechnology Research Centre (PMBRC) at Waterford Institute of Technology (WIT) is an Applied Research Enhancement (ARE) Centre, funded by Enterprise Ireland. The PMBRC’s research expertise includes pharmaceutical characterisation; formulation and polymeric drug delivery technologies; process technologies; biomedical research and biotechnology.

The Centre has a range of analytical equipment to support this research. Pharmaceutical impurities can arise during the manufacture and/or storage of the drug and can influence the efficacy or safety of the product. For EirGen Pharma, an impurity problem represented a significant barrier in the development of their Eir-010 drug as international pharmaceutical regulations require that impurities present above a certain level should be identified. Supported by Enterprise Ireland’s Innovation Voucher scheme, EirGen Pharma engaged the PMBRC to analyse and identify three unknown impurities in Eir-010, which were observed to form under storage conditions.

The PMBRC used a combination of analytical techniques, separation and spectroscopic techniques to determine the structure and identity of the three impurities. EirGen Pharma was able to use the data generated by the PMBRC to support the filing of Eir-010 with the European Medicine Agency (EMA). Eir-010 was subsequently approved by the EMA and will be commercially launched in key European markets with sales worth €20m forecast over the next five years.

Testimonials

“We hear a lot of commentary about the ‘Smart Economy’ and the need for Ireland to move up the value chain – the research work of the PMBRC is a firm example of that going beyond rhetoric in the pharmaceutical sector. Our partnership with the Centre is a key part of our vision for EirGen Pharma and the working relationship has already been a very productive one on several levels – perhaps most starkly when research at the Centre allowed us proceed with a key drug in our portfolio that might otherwise have been abandoned.”
Tom Brennan, Technical Director and Co-founder, EirGen Pharma Ltd.

“Partnerships with industry are a huge part of the Centre’s work and we very much see our mandate as being to use the talent and facilities we have to support indigenous and multinational companies in this sector. The timeline for EirGen Pharma’s growth over the period since their formation in late 2005 has mirrored our own growth under the leadership of people like principal investigator and founder, Dr Peter McLoughlin, and the team that has grown in the same period.”
Dr. Niall O’Reilly, Manager, PMBRC, WIT

Client: EirGen Pharma Ltd.
Institution:
Waterford Institute of Technology
Industry: Pharmaceuticals
National Priority Area: Therapeutic Synthesis, Formulation Processing and Drug Delivery

Head of Research
Dr. Willie Donnelly
Waterford Institute of Technology
Cork Road, Waterford
Ireland
T: +353 (0)51 845 596
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External Services Manager
Kathryn Kiely
Waterford Institute of Technology
Cork Road, Waterford
Ireland
T: +353 (0)51 302 034
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Centre Manager
Dr. Niall O’Reilly
Pharmaceutical and Molecular Biotechnology
Research Centre
Waterford Institute of Technology
Cork Road, Waterford
Ireland
T: +353 (0)51 306 167
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