Biopharma SPOKES Project

Advanced Biopharmaceutical Technologies Research Collaboration

Biopharma SFI Spokes Project ‘Facility of the future – the plastic factory, enabling single use technologies’

The SSPC vision is to establish Ireland as a Global Hub for Pharmaceutical Process Innovation and Advanced Manufacturing and the Biopharma Spokes is directly aligned with this vision, expanding the breadth of SSPC research to include large molecules by bringing together the expertise and facilities of the National Institute for Biopharmaceutical Research and Training (NIBRT). This industry-academic research collaboration across the small and large molecule is unique internationally and will provide Ireland with a significant competitive advantage. The research programme has been developed in collaboration with industry partners who have selected a specific strand of research considered a priority for the sector. The manufacture of biotherapeutic drugs is complex and costly. Driven by the need to improve quality, this project involves some of Ireland’s leading scientists and engineers working with industry partners to develop innovative single-use disposable plastic bag systems for bioprocessing.

Publications arising directly from the Spoke
C. Ta and J. Bones, Development and validation of an ultra-performance liquid chromatography method for the determination of bis(2,4-di-tert-butylphenyl)phosphate and related extractable compounds from single-use plastic films. J. Chromatogr. A. 1492 (2017) 49-54.
N. Dorival–García and J. Bones. Monitoring Leachables from Single-Use Bioreactor Bags for Mammalian Cell Culture by Dispersive Liquid-Liquid Microextraction (DLLME) followed  by UHPLC-QToF-MS. J. Chromatogr. A. ACCEPTED.
N. Dorival–García and J. Bones. Evaluation of Solvent Systems for Optimized Extractables Studies of Single Use Bioprocessing Solutions. J. Chromatogr. A. ACCEPTED.
Kelly PS, McSweeney S, Coleman O, Carillo S, Henry M, Chandran D, Kellett A, Bones J, Clynes M, Meleady P, Barron N. 2016. Process-relevant concentrations of the leachable bDtBPP impact negatively on CHO cell production characteristics. Biotechnol Prog. 32(6):1547-1558.
Xie Y, Tong M, Abramczyk O, Bones J and Davey G. A look behind the scenes: when CHO cells encounter leachables. (To be submitted to Cell Research, Impact factor:14.812)
Xie Y, Abramczyk O, Tong M, Ruether M, O’Brien J, Hayes J and Davey G. Dose-specific metabolic rewiring of CHO cells- the dichloroacetate tale revisited and revised. (To be submitted to Biotechnology & Bioengineering, Impact factor: 4.164)

Funding
Launched in November 2014 and valued at over €1 million, the Biopharma Spokes is due to complete in September 2017. This SFI SPOKES award is co-funded under the European Regional Development Fund 2014-2020.

The Team
This team brings together a unique mix of strengths across diverse but relevant disciplines. Academic Partners: Prof. Gavin Davey (TCD), Dr. Ken Mok (TCD), Dr. Jonathan Bones (NIBRT), John Milne (NIBRT), Dr. Jerrard Hayes (TCD), Dr. Niaobh McLoughlin (NIBRT), Prof. Martin Clynes (DCU), Dr. Niall Barron (DCU), Dr. Paula Meleady (NIBRT), Dr. Colin Clarke (DCU), Dr. Andrew McDonald, (TCD), Prof. Brian Glennon. Industry Partners: Eli Lilly, Pfizer, Merck, Genzyme, Janssen, Allergan, Biomarin. Project manager Aisling Arthur, SSPC.

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