July 2011

Ireland's new bioprocessing institute

New Irish facility provides research, training and education for all aspects of bioprocessing. 

  
The National Institute for Bioprocessing Research and Training recently opened a new facility in Blackrock, Co. Dublin.


The National Institute for Bioprocessing Research and Training is an initiative led by four of Ireland’s top academic institutions: University College Dublin, Trinity College Dublin, Dublin City University and the Institute of Technology Sligo. The driving motivation behind the creation of NIBRT was to bridge the gap between the pharmaceutical sector and academia by developing world-class training programs for students and industry professionals and ensuring the creation of a workforce with the specific skills and competencies needed in industry. In 2006, the Irish government provided seed funds exceeding U.S. $100 million for the project, which now is considered to be a national resource with a catalytic role in the growth and advancement of the biopharma sector. NIBRT’s mission has three parts: training and education, research, and providing state-of-the-art multipurpose facilities to house the research and training functions.

A new facility

NIBRT’s research labs originally were housed in the UCD Conway Institute of Biomolecular and Biomedical Science pending construction of a new facility in Blackrock, Co. Dublin. The new building was completed in late February, and research staff have now moved in.

The state-of-the art facility houses a small-scale upstream and a downstream bioprocessing pilot plant designed for factory scale-up operations – a concept completely unique to such an institute. The large suites host cutting-edge equipment used during the multistep bio-production process. The upstream plant consists of four bioreactor skids for mammalian cell culture, cross microfiltration and centrifuge systems for product harvesting, and an inoculum preparation lab. These are complemented by UF/DF skids in the downstream plant for product concentration, chromatography skids for the recovery and purification of protein products, and vessels for the virus inactivation step.

  
NIBRT’s new facility is considered to be the most strategic investment to date in Ireland’s biotechnology sector and a key industry asset.

Also incorporated in the building are interactive spaces and seminar rooms to host meetings and events that serve NIBRT’s educational programs. NIBRT aims to provide a comprehensive and practical experience, so the facility simulates recognized standard good manufacturing practices. This integrated approach brings together in-depth basic training as well as a hands-on practical experience in its applied industrial context.

NIBRT’s new facility is considered to be the most strategic investment to date in Ireland’s biotechnology sector and a key industry asset.

The training 

NIBRT hopes to provide academic educational modules to students and industrial training tailored to the needs of its pharmaceutical partners. The academic educational programs are geared toward both undergraduate and graduate students. In conjunction with its academic partners, NIBRT offers masters degrees in biopharmaceutical science and bioprocessing engineering. This education model is a core strength of the institute since it prioritizes translational research and knowledge transfer. Students benefit from the combined expertise of academic scientists and industrial partners who work in NIBRT’s labs.

The industry training program offers a comprehensive set of fully accredited modules. They include introductory modules that deal with the principles of biotechnology, upstream and downstream technology modules, and facility design and bioprocessing regulatory modules. Courses are highly flexible and are designed to be modified according to the industrial client’s needs. Furthermore, training is delivered either at the NIBRT facilities, at the client’s site or via distance learning. A list of unique training partnerships with companies such as Pfizer, Centocor, Eli Lilly, and more recently Honeyman and Pall Corporation already have been established.

NIBRT works closely with the client company to identify and analyze specific needs, and then designs customized courses that ensure optimal training relevance. For example, NIBRT joined forces with Pfizer following the establishment of its monocolonal antibody facility in Cork, Ireland, and implemented a graduate certificate in bioprocessing for its operating personnel. As a result, Pfizer was awarded the Continuous Professional Development Company of the Year Award in 2009 by Engineers Ireland.

The Eli Lilly collaboration consisted of delivering training courses in new biopharma operating technologies and aseptic manufacturing protocols. Another recent training collaboration was the design of an interactive course for Pall Corporation that was targeted to manufacturing operators and intended to ensure thorough understanding of accurate testing of filter integrity, which is critical for efficient and safe pharmaceutical production and regulatory compliance.

Balancing basic and translational research  

NIBRT’s innovative concept is based on maintaining a balance between fundamental basic research and applicable industrial research. A range of studies are conducted at NIBRT under the supervision of principal investigators with extensive industrial experience. Projects cover key issues in the optimization of bioprocesses. They include investigating protein aggregation during therapeutic product packaging, development of solid glycotechnology for quantitative and detailed structural N- and O-glycan analysis, development of an Fc receptor platform to evaluate IgG biological activity, assessing the impact of single-use bioreactors on media components and protein product integrity, and quantitative analysis of complex cell culture media and bioprocesses broth.

NIBRT already has a broad array of research collaborations with major biopharma companies such as Roche, AstraZeneca, Merck, BD Biosciences, Eli Lilly, and Waters. The first partnership, announced by NIBRT in 2006, remains a successful ongoing long-term research program with Organon (Akzo Nobel). The project aims to advance the understanding of the regulation and expression of glycosylation enzymes in CHO cell culture and is carried out by Gavin Davey at Trinity College Dublin in collaboration with the NIBRT Dublin-Oxford Glycobiology Lab. The lab, led by glycomics expert Pauline Rudd, has developed a state-of-the-art proprietary high-throughput glycan analysis technology platform. In collaboration with Waters Corporation, the group has built and maintains the world’s first database for glycan analysis by ultraperformance liquid chromatography.

  
NIBRT aims to provide a comprehensive and realistic experience, so the facility simulates recognized standard good manufacturing practices.

NIBRT’s expertise in the glycobiology area has led to an impressive number of industry collaborations. For instance, Agilent’s goal is to analyze protein glycosylation in the context of recombinant protein drugs and to study glycan biomarkers of disease (2010 collaboration); Roche is looking to develop and optimize an HPLC glycan assessment technology (2009 collaboration); and Eli Lilly is developing glycan analytical technologies for monitoring cell culture conditions (2008 collaboration). More recently, NIBRT and Rudd’s Group joined with the Glycomics by High-throughput Integrated Technologies consortium, which works toward developing novel glycosylation technologies for cancer diagnostics. Outside of the glycobiology area, NIBRT has set up a research partnership with BD Biosciences for cell culture media characterization and optimization.

NIBRT’s strong alliances with industry have earned it a reputation of excellence and provide a great example of shifting innovation. The new facility is built to the highest global standards and further anchors NIBRT’s role in the Irish life-science industry. NIBRT now aims to establish new startup collaborative research ventures and to help Ireland continue to compete for international biopharmaceutical investments.

Joanna Fares (faresj@mail.nih.gov) is a doctoral candidate in the Graduate Partnership Program at the National Institutes of Health and Georgetown University.


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