“If you think about needing to produce product for about 1000 patients a year, and our current batch records can run anywhere from 400-600 pages per batch, you start getting into the millions of pages of documents that you have to manage [...] There’s a need to transition those to electronic batch records; but we can go even further towards a ‘failure by exception’ process, where there’s a lot more automation in the sense of capturing the information that’s coming out of your QC testing and filtering it effectively, so you’re only stopping the disposition process when things are not obviously meeting your spec.”
~ Steven Goodman, Head of Drug Product Manufacturing, bluebird bio
“In taking the lens of the patient and the hospital provider, we were able to have real conversations about things that should be an industry utility. So when we think about labels and the data fields on labels, or the audit approach and how we reduce the level of impact […] these were some of the areas we were able to align. And my hope is that the same mindset can transfer over to where you have cell and gene therapy publications, where there are people who have done really great work, putting it out there as open source code so that folks can build and iterate on that.”
~ Peter Olagunju, SVP, Technical Operations, FerGene
“I do think the cell and gene therapy industry will go a similar way to monoclonals, but I think it will be for very different reasons. Monoclonals had that inflection point when cell line engineering and cell specific productivities went through the roof. Cell and gene is so multimodal that I don’t think there will be a single technical advancement […] So as an overall industry, we are headed in the same direction, but our technical challenges – and the multiple different manufacturing modalities – are going to make for very different mechanisms of how we get there.”
~ Gary M. Pigeau, Director, Centre for Advanced Therapeutic Cell Technologies, Cytiva
Steven Goodman, Peter Olagnunju, and Gary M. Pigeau, were all speakers at Reuters Cell and Gene Therapy USA 2020: https://bit.ly/2SLdu4D
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