Up next in our series of conversations with experts at The World Vaccine Congress in Washington is an interview with LumaCyte’s Renée Hart, who joined us at the Congress for a roundtable: “Fix your viral process”. Renée is President and Co-founder of LumaCyte, a novel, label-free, single-cell analytic that is used in vaccine development and production.
Fixing the viral process
Our first question explores the roundtable that Renée and her colleagues delivered. She reflects that historically, and even currently, vaccine manufacturers rely on historical averages for TCID50 or the viral infectivity analytic.
“The challenge with that is that every vaccine production run is slightly different, and so the viral titer could be higher, it could be lower…it does result in some added specification or batch failure events.”
However, a real-time viral titer can be delivered in 5 minutes with LumaCyte’s technology.
“The power of that real-time viral titer is really transformational, because you now understand where in your manufacturing process your viral titer is.”
This enables manufacturers to “assess the situation” before scale up, improving the consistency of manufacturing.
“The other real power in that is that, not only are you getting a more consistent production run, but you also are able to dose the vials more appropriately.”
Renée’s “third reason” is that when you know the viral titer, and understand its accuracy, you can “predict, and extend in many ways, your shelf life”. This is “really powerful for pandemic preparedness”.
Bringing innovation to the community
We then asked Renée a bit more about this technology, and she explains that Laser Force Cytology is a novel technology, developed over the last 24 years.
“We’re really being seen as a forward-looking technology.”
An area that the team found unexpectedly powerful is comprehensive cell characterisation: being able to comprehensively understand “what that cell is today, but what it will look like tomorrow”. This means developers and manufacturers can assess the strength of the cell.
“That has profound impact.”
A recent and exciting update is that the cellular starting material of PBMCs can be correlated to the killing assay. Accessing this knowledge “upfront” is “really powerful”.
Meeting unmet needs
It’s interesting to consider how these technologies fit into the vaccine community, and we asked Renée about how she views LumaCyte’s presence here.
“We’re filling an unmet need in a couple of different areas.”
Renée shares that the FDA invited the team to train all of their cell and gene therapy reviewers, during which LumaCyte’s solutions emerged as a clear need for the industry:
“They said that the industry doesn’t realise the challenges around a faulty understanding of cell health…we hadn’t realised the power of our technology.”
Alongside this, LumaCyte and NIST are working closely on cell fitness and better characterisation, pressure testing the technology in a range of ways. Renée considers the many possible changes that can “have a really big impact”:
“If you can understand that upfront, with your analytic, like immediately at the beginning, you wouldn’t waste all that time…”
Another “eye-opening” aspect is the real-time viral titer, which is a “really powerful” upgrade on existing technologies.
“The FDA is very excited about something that is easy, it’s precise, accurate, and we’re automated.”
Why WVC?
Finally, we ask about the Congress and what Renée and her team were achieving with us. Renée suggests that “it’s been a really nice conference; it always is”! While we are glad to welcome LumaCyte back to the event, they have seen the remarkable growth. They were also part of the ViE Awards this year, nominated and shortlisted, for Best Process Development and Production Technology, a category in which the team was highly commended! Another highlight was the session with FDA’s Dr Peter Marks, in which he stressed the importance of cellular analytics!
“We’re just proud to do our part; the community is a very special community; it’s a hardworking community, they care deeply.”
It was great to hear Renée’s insights and we hope that you enjoy the interview!
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