Author: Killian O'Driscoll, projects director, National Institute for Bioprocessing Research and Training
The National Institute for Bioprocessing Research and Training (NIBRT) is a world-class institute that provides training and research solutions for the bioprocessing industry. Our mission is to support the bioprocessing industry by providing a unique learning experience for trainees in an environment that replicates the most modern industrial bioprocessing facility. In parallel, we also undertake leading-edge research in key areas of bioprocessing in collaboration with industry.
NIBRT is based on an innovative collaboration between University College Dublin, Trinity College Dublin, Dublin City University and the Institute of Technology, Sligo. NIBRT was primarily funded by IDA Ireland (Industrial Development Agency), to assist with the attraction and development of biopharma foreign investment in Ireland.
NIBRT offers a quality training and research experience not previously possible anywhere in the world.
The life sciences manufacturing industry is a critical component of the Irish economy, generating exports of €55 billion in 2011 (50% of the national total), €3 billion in taxes and with a total employment of 60,000 (Source: PharmaChemical Ireland’s Ireland – the location of choice for scientific investment, 2011). However, this ‘jewel in the crown’ of the Irish economy is facing unprecedented challenges.
The pharmachem sector (‘small molecule’), in particular, is under pressure from a diverse range of challenges, including the advent of the patent cliff, excess global manufacturing capacity, limited product pipelines, with a consequent modest global growth target of 6% to 2016 (1). These challenges have contributed to a period of consolidation and cost optimisation in the industry.
At the same time, there is significant opportunity for growth in the related biopharma sector (‘large molecule’). The world market for biopharmaceuticals in 2012 was greater than $140 billion; growing at 15-18% annually (2) and by 2016, seven of the top ten blockbuster drugs will be biopharmaceuticals (3).
It is now estimated that 50% of medicines in the global pipeline are derived from biotechnology, with 700 biosimilars/biobetters in the development pipeline (4). It is predicted that job losses in the traditional small molecule pharmachem sector from 2010 to 2015 will be offset by job gains in the biopharma sector (5).
Following extensive consultation with industry and academia, the Irish Government decided to address these challenges and opportunities by establishing NIBRT, which officially opened in Dublin in June 2011.
FACILITIES
[caption id="attachment_12239" align="alignright" width="940"]
NIBRT is located on the UCD campus[/caption]
The NIBRT building is a purpose-built, multi-functional facility which replicates the most modern industrial bioprocessing facilities. Located on the grounds of the UVD campus, the total building area is approximately 6,500 metres squared. At the heart of the NIBRT building is the bioprocessing pilot plant, consisting of extensive upstream, downstream, fill-finish and the associated analytical facilities. These facilities are all operated in a realistic GMP simulated, operational manufacturing environment.
The facility also provides extensive research laboratory areas with ample capacity for PMTC research teams and for client companies. The laboratories include the Waters Centre of Innovation, which provide access to the most up-to-date analytical equipment as part of NIBRT’s strategic partnership with Waters (6).
In 2012, the NIBRT facility was awarded the ISPE/Interphex Facility of the Year Award for Novel Collaboration. This is the international pharmaceutical industry’s premier awards programme, dedicated to celebrating innovation and accomplishments in facility design, construction and operation (7).
With regard to training, NIBRT provides a broad range of training and education programmes to a wide variety of companies, including Merck Sharp & Dohme, Amgen, Lilly, Johnson & Johnson, Pfizer, Elanco, Genzyme and Allergan. NIBRT training is based on a ‘Five Cs’ model, where the ‘Cs’ represent:
- Competency-based learning;
- Customised courses;
- Certified programmes;
- Continuous professional development;
- Cost effective.
Working with its academic partners, NIBRT also provides comprehensive education programmes for undergraduates, MSc students and for people who are looking to cross-skill for the biopharma industry.
RESEARCH
[caption id="attachment_12237" align="alignright" width="728"]
Trainees in NIBRT's upstream pilot plant[/caption]
NIBRT research is based on a foundation of scientific excellence and is focused on delivering practical solutions to the biopharma industry. Research solutions are tailored to meet specific client requirements. These solutions include contract research, consultancy and collaborative research projects. Key research themes include:
- Advanced manufacturing competitiveness
This focuses on the development and application of science and technology to improve the quality and efficiency of advanced manufacturing processes and products. It is a broadly defined theme which provides considerable scope for interdisciplinary research to support Irish-based industry to develop/win new projects by fostering academic research collaborations.
The theme encompasses future industrial trends to enable Irish-based industries to develop pioneering processes and products, as well as attracting foreign direct investment.
By way of example, through its interactions with its pharmaceutical client base, NIBRT has identified the requirement for a critical research mass, focused on the development and modification of streamlined mammalian production systems for the realisation of maximum specific productivity and associated quality, in both the traditional innovator and biosimilar production arenas.
A key feature of this programme is the relationship between bioengineering, biomaterials, bioanalytics and systems biology multi-omics methodology with process analytical technology and associated ICT supporting platforms for data management, mining and knowledge-driven decision making.
- Production of novel therapeutics
This research theme focuses on developing and aligning the existing research competence in Ireland to build an industry leading position in supporting the development and production of novel therapeutics. It encompasses targeted research projects from a broad range of life sciences and ICT competencies. Projects include topics from the development, characterisation, process optimisation, process monitoring and data management required for novel therapeutics.
NIBRT’s strong track record of managing collaborations between industry, academia and Government institutions was recognised in 2012 when NIBRT was awarded the Manufacturing Collaboration of the Decade Award by Bioprocess International.
SUMMARY
NIBRT is a world-class institute that provides training and research solutions for the bioprocessing industry. Our mission is to support the bioprocessing industry by providing a unique learning experience for trainees in an environment that replicates the most modern industrial bioprocessing facility. In parallel, we also undertake leading-edge research in key areas of bioprocessing in collaboration with industry.
References
(1) http://files.pharmaventures.com/api_manufacturing_white_paper.pdf (mainly based on growth in BRIC countries)
(2) Rader, RA. Biopharmaceutical Products in the US and European Markets (database), BioPlan Associates,
www.bioplanassociates.com/publications/pub_bpuseu.htm
(3) http://www.marketsandmarkets.com/Market-Reports/biopharmaceutical-323.html
(4) What Europe has to offer biotech companies? Ernst & Young
http://www.europabio.org
(5) http://www.forfas.ie/publication/search.jsp?ft=/publications/2010/title,6970,en.php
(6) http://www.waters.com/waters/en_US/Professor-Pauline-Rudd%2C-NIBRT%2C-Dublin%2C-Ireland/nav.htm?locale=en_US&cid=134671201
(7) http://www.facilityoftheyear.org/home2
This article is reproduced with kind permission from Irish PharmaChem.