In recent years, the cell culture company Nucleus Biologics has been at the forefront of market disruption. In this interview with David Sheehan (CEO), we explore how the company has been growing its team, expanding its production capabilities, launching new products, and impressively, rolling out the world’s first online portal for instantaneous custom cGMP cell culture media configuration.
The pace never slows when your mission is to enable lifesaving science!
Cade: Tell us what Nucleus Biologics has been up to since the last time we spoke in 2018?
David Sheehan: First Cade, thank you for checking in on us. I would remiss if I didn’t highlight Bioinformant’s growth in readership and vital contribution as an information source for cell and gene therapy. Thank you.
It has been an amazing two years. We continue driving reproducibility by innovating new products supported with good science.
A few highlights:
First, the team has grown dramatically and we have added some industry heavyweights in key areas.
Second, we’ve launched basal and custom media products in addition to our protein reagents.
Third, we acquired a recombinant protein platform through the acquisition of Primorigen and Vitronectin XF in 2019.
Fourth, we developed a new T Cell media with U Penn called NB ROC.
Finally, we have expanded our production capabilities by adding 6000 sq ft of segregated cGMP manufacturing and implementing an electronic quality management system including electronic batch records.
We have also refined our mission statement and are moving to fill a void in cell and gene therapy by focusing on solutions that speed the time from discovery to cure. We are also pushing a message of transparency and trying to ensure that industry is serving the scientist from discovery through to bioproduction.
Cade: Wow, that sounds like a busy two years. Tell me more about how your mission addresses the big challenges facing the cell and gene therapy?
David Sheehan: The cell and gene industry is in a state of entropy as it rapidly grows. We see this as an organic evolution that is extremely healthy as a variety of cells, genetic modifications and ex vivo cell manipulation and expansion reactor platforms are considered. The power in this effort is the diversity of ideas and approaches.
I have heard frustration firsthand from the doctors developing these therapies that cell culture media is critical but that proprietary sole sourced formulations are difficult to improve and have caused supply chain risk. How can we build a biological therapy model on sole-sourced, black box cell culture media?
The answer is we can’t. It needs to change. If you are a scientist using a company’s proprietary formulation to grow your cells, it is akin to building a house on someone else’s land. Why?
Let me go deeper — every therapy company has a unique combination of bioreactor, cell of interest, gene, gene delivery, ex vivo protocol and ultimately media. Further, every therapy developer has different Critical Quality Attributes they are trying to enhance in that finished product. The only way to do that is to customize media and process. But how can you customize media when you don’t know the ingredients? It is madness because it wastes time and resources through iterative and blind trial and error in the lab.
We as an industry can’t gild our margins by being secretive with our customers. We need to destroy that model and rethink how to speed that discovery process. That was the impetus behind our latest product NB-LuxTM.
Cade: I saw the Press Release about the launch of NB-LuxTM. Tell us more about that.
David Sheehan: Sure, Cade, I am super excited about that launch and what it means. So we recognized that off-the-shelf, proprietary, cell-specific media was not meeting customer needs. At the same time, full custom media took 5-6 months to produce. There were no great alternatives if you were the scientist and your company wanted to get into the clinic quickly. To do this, you need to rapidly lock your ecosystem.
We imagined a web-based platform that allowed for customization of any of the core ingredients from amino acids, salts, vitamins, proteins, cytokines and growth factors. Further, we made it so you could select lot sizes from 2 L to 2000 L and you could select any testing required.
Finally, we designed a fulfillment process that delivered the product in less than 12 weeks. In short, NB-LuxTM allows you to get instantaneous quotes for media you own and can iterate that can be delivered, in some cases, in as little as 9 weeks.
Cade: What is the meaning behind the name NB-Lux?
David Sheehan: Glad you asked. Lux is a unit of illuminance. The logo is NB for Nucleus Biologics and a flashlight as the hyphen. The concept is we are illuminating a new path. We are bringing transparency and visibility to cell culture media.
We are creating a paradigm that is focused on collaboration and speeding proven therapies into the clinic. We believe that if this message resonates with scientists, they will support the mission by supporting Nucleus.
Cade: Do you think it will be hard for scientists to leave the security of ordering from a large multi-billion dollar company?
David Sheehan: There are already early adopters using the NB- LuxTM site in the first week after launch, but we are not so naïve or idealistic that we believe the science community will en masse leave the status quo. But I would say to our community: it is not security the large companies bring but subjugation.
Once you design your system with their proprietary media, you can’t improve it because you don’t know the ingredients, you can’t get a second source and you can’t shop to get the best price. Control by industry does not speed science.
We all have a choice, a vote on how we want the science community to evolve. That vote happens when you pick a path and buy cell culture media. I believe most scientists will vote for custom media that is more transparent, cost-effective and ultimately owned by the therapy provider as part of their corporate IP. Vote with your wallet, vote with logic, vote for the future.
Cade: It sounds like you have a full plate of activities, can you share what is next for your organization?
David Sheehan: Sure. We think about our pipeline of products in terms of solving needs. We recognize that NB- LuxTM is a powerful platform for reshaping how media is configured and consumed. But we also realize that scientists don’t always know what components to add or what concentrations. We are thinking about workflows and tools that can assist the scientists getting to optimized formulations faster. This is a major effort underway now.
We also have to address the massive environmental footprint of cell culture media. My estimate is somewhere around 50 Million PET single use bottles per year are put into landfills. That is not sustainable. We may be solving disease but killing the planet. That is something we as a company think about a lot. How do we change that paradigm? We don’t have the answers now but stay tuned.
Cade: Sounds like a lot of things are in the pipeline. We’re excited to see your future disruptions.
David Sheehan: We get caught up in our mission to shake up the cell media space and think of ourselves as activists in this area. However, there is a lot more going on in this country that we need to be aware of and be activists in as well. Recent events have served as a wake up call, and made us pause and reflect on how we can be better allies to the Black and marginalized communities.
We have a small, motivated and diverse team. Our company is majority female, our leadership team and board have gender and ethnic diversity, and we are thinking of ways we as a small business can make more of an impact.
What questions do you have for Nucleus Biologics or CEO David Sheehan? Ask them in the comments below.