This article is an interview with the Founder and Chief Executive Officer (CEO) of RoosterBio, Dr. Jon Rowley. RoosterBio is an innovative company that provides standardized stem cell product platforms to enable rapid clinical and commercial translation.

Specifically,  RoosterBio’s products are high volume, affordable, and well-characterized adult human mesenchymal stem/stromal cells (hMSCs) paired with highly engineered media systems.

In this interview, we explore how RoosterBio is “radically changing the use of stem cells.” Enjoy!


Exclusive Interview with Jon Rowley, CEO of RoosterBio

Cade Hildreth: What is your background and how did you get involved with mesenchymal stem cells?

Jon Rowley: My background is Biomedical Engineering, and I did my PhD in a lab focused on establishing design criteria for a new field (at the time) called Tissue Engineering. We were working on creating environments outside of the body required for guiding individual cells towards fully functional tissue for transplantation.

A fascinating aspect of tissue engineering is that biology has made sufficient progress. It’s now possible to create tissues and organs from individual cellular building blocks – or as the synthetic biology world likes to say, we “build with biology.” Cells, and stem cells specifically, are no longer simply a tool for scientific research, but are now “Lego blocks” for new things that we want to create.

The biggest challenge for me, and my entire lab, during graduate school wasn’t physically making these new tissues in a petri dish; the bottleneck was actually growing up enough cells to even start an experiment! I look back and realize that 80% of my time was spent growing up cells so that I could start an experiment, and really only ~20% of my time was used for the experimental work required to advance my thesis project.

This was very frustrating, and the pace of work was quite slow. I realized that the entire field of tissue engineering was being held back by the availability of the cells required to build tissues. This realization has driven my entire career, and I’ve spent the past 15 years focused on cell production.

Following graduate school, I realized that, in order to advance the tissue engineering field, we first needed to solve the “Cell Manufacturing Challenge.” I first started working with hMSCs while at Beckton Dickinson, where I managed a team working on one of the first serum free media expansion environments for hMSCs. Here, I got a fundamental understanding of what variables made hMSCs expand, and what functional properties were critical to maintain through the expansion process.

After several years there, I moved to a clinical-stage cell therapy company named Aastrom Biosciences (now Vericell) whose autologous Tissue Repair Cell product (which included MSCs) was in Phase II clinical development. This is where I realized that it’s necessary to view cell culture as a manufacturing process, and I quickly established a formal Process Development team. We worked on product improvements to extend shelf life, reduce cost of goods, and streamline and simplify the manufacturing process. I was able to publish some of this innovative work in Bioprocess International with Brian Hampson, from whom I learned an amazing amount.

After Aastrom, I was charged with establishing a new Cell Therapy Manufacturing Innovation group at Lonza, which was almost 100% focused on establishing scalable platforms for commercial scale MSC manufacturing. At Lonza, I was able to work with amazing people, the most innovative MSC therapeutic companies, and help establish what was called the Cell Therapy Manufacturing Technology Roadmap that was focused initially on hMSCs. I was fortunate enough to be able to publish a lot of this work to help the field advance, as well (see bibliography below).

Over the years I have been privileged to be able to work with, and learn from, many leaders in the cell therapy industry. But I still felt passionate about helping to advance my first technology love – Tissue Engineering. Thus, I quit my corporate job, cashed in my kids’ college funds and started RoosterBio specifically to solve the vexing challenges of cell supply, both in Tissue Engineering and the broader Cell Therapy and Regenerative Medicine industries.

Cade Hildreth: When and how was RoosterBio founded?

Jon Rowley: RoosterBio was founded in 2013 on the dream of accelerating and enabling Regenerative Medicine. We assembled an incredibly dedicated team of people that are both strategic and tactical leaders in Regenerative Medicine. We created a “lean start-up,” fast-to-market business strategy to prove (or disprove) our business model (It worked, by the way).

While the idea for the business came out of my running R&D groups that needed these specific products, there is absolutely no way I could have gotten this off the ground without a co-founder and without the help of everyone that joined us early on. While the initial business model took some iteration, once we had it established, it became very obvious. We have not wavered from our initial mission of greatly increasing accessibility to vast quantities of high quality stem cells, originating with hMSCs.

Once we secured our first customer orders and QC’d our first manufacturing lots (in late 2013), we initiated fund raising and received volunteer work from extraordinarily dedicated individuals that made the core Founding Team. Fortunately, we acquired both early sales and early investors, which enabled the company to compensate employees by 2014.

Each and every person at RoosterBio was working for well below market wages, but the Team was doing this for a reason – because we all believed that we could advance the Regenerative Medicine industry – one customer at a time.

Cade Hildreth: Why the name RoosterBio?

Jon Rowley: I, personally, have always liked roosters. There is a lot of symbolism associated with roosters across the globe, and there is always positive energy surrounding these birds. Roosters are confident, and they are a sign of good luck and prosperity in many countries. I also like the fact that roosters announce the coming of every new day.

I have been waiting (and waiting, and waiting….) for the Tissue Engineering revolution to really begin, and now that RoosterBio is here to help anyone generate vast quantities of cells quickly and efficiently, we are ushering in a new era of efficiency and productivity in the fields of Tissue Engineering and Regenerative Medicine. So the name RoosterBio is meant to proclaim the dawn of a new day in these exciting fields.

Cade Hildreth: What is RoosterBio’s core technology and what are its benefits?

Jon Rowley: RoosterBio’s core technology are the scalable and efficient manufacturing processes created for our hMSCs. The culture processes are designed for speed, scalability, efficiency, and of course, to maintain the critical functional properties of hMSCs. However, our goal is not to do custom manufacturing for customers – we have used our manufacturing expertise to create a scalable, products-based business model.

We design products to enable anyone with basic cell culture skills to generate huge numbers of highly functional stem cells in just a few days. We have accelerated the pace of experiments in our customers’ labs, thus shortening what is called “Innovation Cycle Time.” As we scale our business and gain more customers, we believe this will have a tremendous impact on the entire Regenerative Medicine field.

Cade Hildreth: Why did you choose to focus on MSCs?

Jon Rowley: There are multiple reasons why we initiated our revolution in stem cell supply with human MSCs. The hMSC supply market has been under-serving the R&D community for years. So, first off, we knew there was a significant unmet market need and an appreciable number of dissatisfied customers.

Secondly, MSCs are used extensively in tissue engineering for bone, cartilage, and tendon/ligament engineering, as well as other orthopedic tissues. So this satisfied my personal desire to move the Tissue Engineering field forward.

Thirdly, MSCs are now the most widely published stem cell source, and thus a large part of the cell supply market. Lastly, they are one of the most developed stem cell types, and the manufacturing processes and quality control characteristics are well established compared to many other stem cells.

This is the perfect storm to spawn new innovations, new companies, and new business models like ours.

Cade Hildreth: Why types of clients do you serve?

Jon Rowley: Our customers range from academic researchers to government laboratories to both large pharma and small biotech. The applications that our customers are developing with our hMSCs are really exciting to us. We are enabling work that never could have been done before our products came to market. For example, an academic at a Maryland university recently got a grant to engineer an adult human sized femur. That is a huge piece of bone!

While they had the bioreactor technology, they did not have the capacity to grow up enough MSCs to perform the experiments. Once we came to market, they were an early adopter of our cells, and they recently published this work in the journal Tissue Engineering of a piece of bone 20 times larger than has ever been achieved (Reference below). Another small biotech company has been performing research rescuing ischemic organs with stem cells, but has had great difficulty growing enough cells for whole organ experiments, and having the cells ready for use when the organs arrived, typically on very short notice.

Now, this company is using our 50 Million cell “thaw and use” products for their R&D and making more rapid progress than ever before. There is also a university spin out that is tissue engineering ligaments from hMSCs, and they used to have to purchase 8-10 vials of 1M cells in order to engineer one ligament. That was very expensive. Now they can order a 10M cell vial at a fraction of the cost, and have more cells left over for other purposes.

So, we are addressing real unmet needs for researchers and product developers that are working on tomorrow’s stem cell-based health care products, and it is really thrilling to see the rapid progress that our customers are making.

Cade Hildreth: What are your goals for the company?

Jon Rowley: Our near term goal is to further pursue novel stem cell process development and production solutions in order to help our customers rapidly develop products that can be readily translated into the clinic. RoosterBio is intent on delivering an exceptional customer experience, with each interaction.

We plan to do all of this while building a sustainable business with strong company culture that is innovative, profitable, and is “making a dent” in the Regenerative Medicine Universe by advancing the standard of medical care. Ultimately, we strive to contribute to life saving cures.

Cade Hildreth: How can clients, collaborations, or investors get in touch with RoosterBio?

Jon Rowley: We have a really strong following on Twitter (@RoosterBio) and LinkedIn, and our corporate Blog titled Democratizing Cellular Technologies is very well read. If they are looking to directly contact us they can email us at jon@roosterBio.com or info@roosterbio.com. We will be waiting for their email!

Publications of Interest

  1. Cambell, A., Brieva, T., Raviv, L., Rowley, J.A., Niss, K., Brandwein, H., Oh, S., Karnieli, O. (2015) Process Development Considerations for Cell Therapy, Stem Cells Trans Med, 4(10),1155-63.
  2. Simaria, A.S., Hassan, S., Varadaraju, H., Rowley, J.A., Warren, K., Vanek, P. Farid, S. (2014) Allogeneic Cell Therapy Bioprocess Economics and Optimisation: Single-use cell expansion technologies, Biotechnol Bioeng, 111(1), 69-83.
  3. Pattasseril, J., Varadaraju, H., Lock. L.T., Rowley, J.A. (2013) Downstream Technology Landscape for Large-Scale Therapeutic Cell Processing, BioProcess Intl., March Cell Therapy Suppl., 11(3), 38-47.
  4. Bravery, C.; Carmen, J.; Fong, T.; Oprea, W.; Hoogendoorn, K.H.; Woda, J.; Burger, S.R.; Rowley, J.A., Bonyhadi, M.L.; and Van’t Hof, W. (2013) Potency Assay Development for Cellular Therapy Products; An ISCT Review of the Requirements and Experiences in the Industry, Cytotherapy, 15 (1), 9-19.
  5. Rowley, J.A., Abraham, E., Campbell, A., Brandwein, H., Oh, S. (2012) Meeting Lot Size Challenges of Manufacturing Adherent Therapeutic Cells; BioProcess Intl., March Cell Therapy Suppl., 10(3), 16-22.
  6. Carmen, J.; Burger, S., McCaman, M.; Rowley, J.A.(2012) Developing Assays to Address Identity, Potency, Purity, and Safety: Cell Characterization in Cell Therapy Process Development; Regen Med, 7, 85-100.
  7. Brindley, D.A., Davie, N.L., Culme-Seymour, E.J., Mason, C., Smith, D.W., Rowley, J.A.(2012) Peak Serum: Implications of Serum Supply for Cell Therapy Manufacturing; Regen Med, 7, 7-13.
  8. Brandenberger, R., Burger, S.; Campbell, A.; Fong, T.; Lapinskas, E., and Rowley, J.A.(2011) Cell Therapy Bioprocessing: Integrating Process and Product Development for the Next Generation of Biotherapeutics; BioProcess Intl., March Cell Therapy Suppl., 30-37.
  9. Rowley, J.A.(2010) Developing Cell Therapy Biomanufacturing Processes; Chem Eng Prog, SBE Supplement: Stem Cell Engineering and Processing, Nov 2010, 50-55.
  10. Hampson, B., Rowley, J.A., Venturi, N. (2008) Manufacturing Patient-specific Cell Therapy Products, BioProcess Intl, 6(8), 60-72.

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