The sheer scale of ISSCR 2013, which has attracted almost four thousand delegates, and the proficiency with which it is run, is a major achievement by its organizer and lead sponsor: the International Society for Stem Cell Research and the Harvard Stem Cell Institute respectively. Although some organizational calamities will have almost certainly occurred, I haven’t noticed and I suspect others haven’t either. “The show must go on.”
In the cell therapy industry, our audience is a society with significant unmet medical needs: members who care little for the manner in which we may feel aggrieved by the negative decision of a regulator. The medical problems of the people we attempt to help – our opportunity to contribute to sustainable improvements in global health – remain constant. We need to swiftly dust ourselves off and get on with the job at hand, and be willing to approach the task in a different way the second time around. Even if this necessitates engaging unfamiliar stakeholders and techniques in the development pathway earlier than has been historically observed.
And with this ethos at hand, after a pleasant evening with a truly multi-disciplinary group exchanging their views on cell therapy translation in a waterfront restaurant (and later in an old prison, now converted into a bar), TAP Biosystems’ Kim Bure coined my top phrase of ISSCR 2013: “The process must go on.”
Almost all of the extraordinary stem cell science presented at ISSCR 2013 has been produced using highly labour intensive and poorly reproducible manual processes. This is perfectly acceptable if one’s end goal is to produce a high impact publication in a leading journal. But to me, and I hope to a growing tranche of the cell therapy industry, such publications are merely a stepping-stone towards clinically relevant cellular therapeutics. Products that, for reasons of patient safety, efficacy and commercial viability, need to be highly reproducible.
Reproducible and cost-effective aren’t necessarily characteristics that one ascribes with manual bioprocesses; but with good staff training and significant resources it is of course possible. Nevertheless, in an industrial setting it is mostly unrealistic. Staff illness alone could compromise the production process of a potentially life saving product. Therefore, it is essential to consider the scalability and practicability of protocols employed in a laboratory setting earlier than ever, as engagement with industrial partners is occurring progressively earlier in the development pathways of cellular therapies compared to existing biologics.
Part of the challenge is “removing the art from the process” as convincingly stressed by Lonza’s Thomas Fellner, charged with delivering the company’s collaboration with the NIH to produce large volumes of clinical grade iPS cell lines. For example, if we are to consider process development from laboratory to marketplace as a spectrum between entirely manual and poorly reproducible through to highly automated and highly reproducible, it is evident that progressive, as opposed to aggressive process development, is a mission critical aspect of the development of the Cell Therapy Industry 2027.
No one would suggest that overly aggressive process development, leading to overly engineered lab scale processes, is anything other than unnecessary. Similarly, we would all agree that hindering the progress of life-saving therapies to the clinic due to failing to ensure scalability and reproducibility earlier in the development pathway is anything other than unacceptable.
However your lab decides to conduct its work, remember that “the process must go on”. And, while ‘brute force’ overtly manual techniques may produce nice figures for a publication, they may not always best support the clinical translation of your processes – and patient benefit.
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