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RICC Report Summary

Project ID: 705249
Funded under: H2020-EU.1.3.2.

Periodic Reporting for period 1 - RICC (The Application of Advanced Raman Spectroscopies to the Quantitative Analysis of Industrial Chromatography Columns)

Reporting period: 2016-10-01 to 2018-09-30

Summary of the context and overall objectives of the project

When manufacturing modern biological medicines (biopharmaceuticals), the final steps involve separating and purifying the drugs/proteins using various chromatographic methods.
Protein chromatography columns are very expensive (can be >€1M), and cannot be easily replaced unless there is strong evidence (further along the processing stream) that they are not functioning properly, or that they have begun to degrade.
This project aimed to develop optical technologies that could be used to monitor the efficacy and health of chromatography columns and let operators know when column degradation started to occur. The biopharmaceutical industry produces important medical products such as drugs, vaccines, and hormones that are vital to modern European society. The development of cutting edge analytical techniques will enable better understanding of industrial processes and could aid the development of new products. More tangibly, the work will have a direct and measurable economic impact; in any process where our technologies can replace more complex and time-consuming “wet chemistry” analytical techniques, costs can be reduced, thus leading to less expensive medicines.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Work performed up until the end of November 2017 (i.e. in the first year of the project)

Scientific Project
The scientific project began as had been proposed in the ‘Implementation’ section of the proposal:
• WP1 - A detailed literature review on the application of Raman and SORS to the biopharma sector was carried out (see outputs below).
• WP2 - A Raman system (a Avalon Instruments Ramanstation which had been made available for the project) was fitted with an external probe and so adapted to collect data in bench-top experiments (see detail in the Tech. Report).
• WP3 - KB was trained by Boyan Li to use Umetrics’ and ‘SIMCA’ software packages
• WP4 - KB used the Raman probe and spatial offsets along the focal axis (i.e. nearer-to and further-from the focal point) to probe model systems made of plastic and various small-molecule model systems (containing alumina/silica stationary phases, various mobile phases and acetaminophen/aspirin/caffeine solutions as samples) and built a robot probe arm to automate the collection of spectra. As things stand, it is proving difficult to resolve interesting information from the collected data and it is suspected that there are issues with the optics of the system (specifically we are looking at the way the signal is imaged on the detector).
• WP5 - Initial measurements were performed on protein columns, specifically on column packed with Sephadex® (cross-linked dextran gel used for gel filtration sephadex) and dilute solutions of Adenine.

• In addition to the main scientific project, KB undertook some general Raman spectroscopy measurements on samples of small molecules supplied by researchers in the SSPC, investigated and characterised the behaviour of another (Kaiser) Raman instrument, and contributed to various scientific investigations/projects in the group.

Scientific Outputs
• Co-wrote with AR “Applications of Raman Spectroscopy in Biopharmaceutical Manufacturing: a short review” and had it published in Applied Spectroscopy. This detailed review will enhance the career of KB by making him more visible in the field.
o Raman Spectroscopy in Biopharmaceutical Manufacturing: a short review. K. Buckley and A.G. Ryder. Applied Spectroscopy, 71(6), 1085-1116, (2017). Focal point article (peer reviewed). An open access version is available on NUIG’s publication server, ARAN.
• Co-author on another publication (in preparation), with the PI and an NBL research student (S. Murphy) which details the use of vibrational spectroscopy for the quantitative analysis of cell culture media hydration.

Exposure to Science in Industry
The supervisor at the host laboratory has a strong record of working with industry on large-scale projects applying spectroscopic methods to bioanalysis issues. In his first year at NBL, KB:
• Worked with the Science Foundation of Ireland’s ‘Synthesis and Solid State Pharmaceutical Centre (SSPC, ’ to address research challenges in the pharmaceutical industry (e.g. attended multiple technical meetings, etc.).
• Completed ‘Lean Six Sigma Yellow Belt’ and ‘Good manufacturing practice’ training.
• Attended (in University College Cork in Oct. 2016) the pan-European Conference on QbD and PAT Sciences and the two-day ‘Process Development and Scale-Up in the Pharmaceutical Industry’ (at NUIG in Apr. 2016) master class which was delivered by industrial practitioners (topics covered included introductions to Process Scale-up of Drug Syntheses, Tech. Transfer, Analytical Science, Chem. Engineering, QA, Solid State Manufacturing & Crystallisation, and Safety/Environmental Management).

The fellowship programme has been designed to provide KB with opportunities to develop academic teaching skills:
• Lecturing: After giving a test lecture to School of Chemistry academic staff, KB lectured the University’s second year students (CH205, Analytical & Environmental Chemistry

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The main outputs of the Fellowship have been in the professional development and training of KB. In August 2015 KB returned, from Canada, to his home country of Ireland and “the primary aim” (from the project abstract) of the fellowship was to facilitate his reintegration with the research community here. His acceptance of a role in industrial R&D at Stryker Corporation in Cork has meant the Marie Skłodowska-Curie has been ended before the scientific research project could be concluded; the Fellowship itself however (which was funded under H2020-EU.1.3.2., ‘Nurturing excellence by means of cross-border and cross-sector mobility’) has been a major success.

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