July 2011

Ireland's new bioprocessing institute

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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