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NIBRT on characterizing E&Ls present in single use bioreactors

Ahead of his presentation at Extractables & Leachables USA 2017, we spoke with Jonathan Bones, Principal Investigator at the National Institute for Bioprocessing Research and Training (NIBRT) about their research into characterizing E&Ls present in single use bioreactors, the analytical techniques used and the results seen, the importance of sharing research projects and more.

Your presentation looks at a case study of characterisation of E&L compounds for single use bioprocessing solutions; can you provide us with a brief overview of what your presentation will look into?

My team at NIBRT has undertaken an in depth investigation to characterize E&Ls present in single use bioreactors using a variety of high resolution analytical techniques. We’ve identified a large number of E&L’s spanning many compound classes. Interestingly, a subset of leachables identified were not detected as extractables, suggesting that these compounds arise as a result of interaction with other compounds present in cell culture media. Multivariate data analysis demonstrated strong correlation with film type and bag age. Investigation of the experimental data suggests that additional guidelines may be necessary to include process related risks as many of the compounds identified may be detrimental to CHO cell performance.

How important is it to evaluate and discuss results of research projects and case studies, such as your presentation, with peers and colleagues in the same industry at E&L USA?

It’s hugely important, I presented the preliminary output of this study at E&L USA last May and got excellent feedback and input from the audience. This feedback was really important in how we designed subsequent steps in the study to ensure maximal impact from the research. The conference provided an excellent forum to interact with key thought leaders in the field, industry colleagues and leading academics, it was a great experience.

As a returning E&L USA speaker, what are you most looking forward to at the conference in May?

I’m looking forward to presenting our data and getting to meet with the excellent delegates that attend E&L USA. Input and advise received at last year’s conference was beneficial to me and the team as we progressed with our large study. I’m hoping to get more of the same this year so that we can progress further in this exciting field.

Dr Bones will be presenting as part of the E&L biopharmaceutical manufacturing session at Extractables & Leachables USA 2017 this May. Other presenters in the session include representatives from Triad Scientific Solutions, PPD, Lonza, Sartorius Stedim and VR Analytical.

You can view the full programme here.