I spent 22 years with Genzyme, a biotech product company, and, at the end of my tenure, I began considering starting my own company. I’d been involved with an entrepreneurial organization called the Saltire Foundation, and the more I heard others speak about their entrepreneurial journeys, the more I became interested in taking that step myself. Many of the companies I was involved with were product companies or innovators, though I had realized clinical and product development weren’t the best fit for me. My whole career had been spent in manufacturing and operations with a life science focus, which led me to conclude that I should look at biologic contract manufacturing as a space to develop the next stage of my career.
I had investigated sites for Genzyme and was aware of some that were still up for sale. In April 2010, I reached out to Johnson & Johnson and told them I’d be interested in acquiring a site of theirs in St. Louis.
After that, my first learning experience was finding the right investors. Contract manufacturing was fairly straightforward; we were basically going to carve out the existing operations with a focused leadership team and about 160 employees. However, we still had to add business development and process development teams to support the site and invest to build out clinical capacity. It took about 13 months before we were fully funded and off the ground.
Gallus was focused on mammalian culture and monoclonal antibodies, but there was a phenomenon that was really starting to mature around 2010–2011: single-use or disposable technology. Before I had funded the business and closed on the acquisition of that site, I had set up a partnership with Xcellerex, which is now a part of GE, to deploy their single-use platform at the St. Louis site. The benefit of single-use technology was it had a somewhat lower capital cost and faster deployment than the slow build-out of stainless steel-based bioreactors; it was generally a more flexible approach for multi-product manufacturing, which helped me develop a plan that would allow us to quickly create additional capacity to support new clients.
Gallus offered the high-quality pedigree of the site and the commercial manufacturing team. Business growth was slow for the first two years, because we were in the process of building both the organization and its reputation while continuing to supply J&J with commercial product. Until we really established more critical mass and built out the plant over the first year to 18 months, it was hard to gain traction with clients.
By the third year, we hit an inflection point. We expanded the use of our process development space and our clinical capability, and were signing up more clients, including for late-stage clinical molecules. These clients were attracted by the commercial pedigree of the site and team and that they could launch their products at Gallus and be supported throughout the life cycle.
Three years in, we acquired a company called Laureate Biopharmaceutical Services, based in Princeton, New Jersey. Most of Laureate’s clients were in phase I/II clinical trials with monoclonal antibodies. This acquisition broadened our pipeline and client base and also gave us more credibility; they had been in business for 12 years. This helped to accelerate our growth and attract more business to Gallus.
Going into our fourth year of that journey, we paid attention to the inbound interest in the company and decided to have a conversation about a transaction. In the end, we went ahead with it and the company was sold to Patheon. We fit into their network of commercial biologic sites and deep customer relationships, thus ensuring the ongoing growth for the Gallus team.
At Gallus, we had a partnership with a cell therapy company. We explored the cell therapy space and talked to about half a dozen potential clients and made some proposals, but we didn’t have a high degree of credibility because we had no activity in that space, so none of those opportunities came to fruition. Once Gallus was sold, I decided to create Brammer Bio to focus on cell therapy, and, after another 13-month journey with the support of a partner and others, really came to appreciate that the strongest opportunity was to supply the viral vectors needed for both gene-modified cell therapies and gene therapies.
Exploring acquisition opportunities jump-started Brammer Bio, especially when we were reintroduced to the Massachusetts-based private equity group Ampersand Capital in early 2016. Ampersand had invested in Florida Biologix in November 2015, helping the founder, Dr. Richard Snyder, to spin the company out from the University of Florida. Ampersand recognized that this was a fantastic organization comprising about 100 people with excellent technical experience focused on early stage development for gene therapies. The opportunity was really to build a late-stage pipeline with the existing clients and to attract new clients. Of course, I spent much of my career doing late-stage clinical supply and commercial supply and so the relationship was symbiotic. We merged with Florida Biologix to create Brammer Bio at the end of Q1 2016.
Back in the early 1990s, Genzyme was a pioneer in gene therapy for cystic fibrosis and conducted some of the first in-human clinical trials. Genzyme was also a pioneer in regenerative cell therapy, and had the first FDA-approved cell therapy product in the late 1990s. In 2006, I established a site for clinical gene therapy manufacturing for Genzyme. In 2016, it became clear that the demand for viral vectors was really starting to build. In the summer of 2016, we negotiated to acquire two sites from Biogen and bring about 100 people over with commercial biologics experience. We announced this in November 2016 and completed the deal on January 1, 2017. That action drove a lot of inbound inquiries from companies that were entering phase III clinical trials and needed to establish a commercial source. They viewed it as less risky to switch to us than to continue with CDMOs that lacked commercial experience. In early 2017, it was clear that viral vector demand was starting to explode; we made the strategic decision to not return to cell therapy manufacturing. We committed to a $200 million capital investment program to provide the capacity needed for clients. We started the development of a second commercial site in Lexington, Massachusetts.
We’d grown the company from 100 people to 600 people over three years and we’d invested $200 million (which is an extraordinary amount for a relatively small company), so we’d taken a lot of risks to be ahead of the curve. I didn’t do this all alone, of course; I had partners I was working with and a strong leadership team that played a very crucial role in executing on these plans because, if you don’t execute, you quickly find that you’re not going to grow rapidly — execution is core to maintaining momentum and growth.
We were faced with a strategic decision at the end of 2018, which was to either raise additional capital for investment in further capacity — beyond what we were already doing with the first $200 million — and over the next 2–3 years double the size of the team again, ourselves, or we could do this as part of a larger organization with deep resources. We had received inbound inquiries from companies that were interested in getting into this space which we decided to explore more deeply. Early in 2019, we concluded that the better route was to become part of a larger services organization.
We knew that we had created something special, but when you’re on a trajectory that is basically an exponential curve, you’re faced with a unique dilemma. It’s not like being in a business where you’ve got a steady 10–15% annual growth. Instead, you’ve got this exponential growth so the discussion becomes: do we wait a year? The challenge was funding the next stage of growth, which would take 2–3 years. That was the dilemma of having something that’s going very well, and so we ultimately decided to accept the offer from Thermo Fisher Scientific, which has deep resources and experience that will accelerate our growth to serve clients.
The humbling piece of this industry is that it’s all about execution. Of course, having a vision and a plan is vital, because you can’t get investors on board if you don’t have a plan — but, once you’ve got the investment in place to support that plan, it’s all about execution. In our business of serving clients, they are entrusting you with their product, which, in the case of smaller clients, may, in essence, be the company — it’s an awesome responsibility that a service provider takes on.
For me, customer service and engaging with the client is crucial. With Brammer Bio, we focused on values comprising the acronym “BEST,” which stands for Brilliant science, Extraordinary service, Setting standards, and Trust, empowerment, accountability and me. When you recruit people from innovator companies, you have to explain the differences in being part of a service organization, and what matters is delivering on client commitments. Similarly, when we provide our early stage development and clinical supply, clients may be waiting for that first GMP batch in order to get it into the clinic and prove that they have a product. Fundamentally understanding what a service business looks like and how to organize around that is key.
The other piece of this success is that every employee has a bonusable element of their compensation tied to two things: the financial performance of the company and the operational performance, which includes everything we have to do to deliver. We have a track record of being able to pay that bonusable amount each year throughout both Brammer’s and Gallus’ histories. Achieving this is about keeping the goals visible to everyone in the organization and connecting those goals to individuals, while emphasizing personal and team responsibility.
Another lesson I learned at Genzyme is that you can’t wait until you have perfect information. You’ve certainly got to do your analysis, speak to people, and be aware of opportunities and strengths, but, at some point, you have to go with your gut and trust what you’re going to create. You have to believe that the business will grow. Of course, you learn lessons along the way that can reshape what you’re doing, but, fundamentally, you’ve got to go with your experience and intuition. If you wait until everything is sewn up, you’ll be too late — others will have already done it.
I continue to believe that there are areas in manufacturing and delivery that challenge the life sciences, in general. A tremendous amount of the pipeline is in smaller, innovator companies who don’t want to invest in manufacturing themselves, for example. I believe there continue to be opportunities to support those innovators through the application of manufacturing excellence. Whether in a direct or supporting role, there’s an opportunity for me to help the industry continue to grow and bring products to patients to improve and save lives.
I’ve been involved with Entrepreneurial Scotland and the Saltire Foundation for 11 years. The Foundation creates opportunities for seniors at Scottish universities to pursue internship opportunities abroad and for more seasoned applicants to visit Babson College in Massachusetts to learn about a global view. The program encourages these entrepreneurs to return to Scotland with the tools needed to build companies. It’s a challenge for a small country to build businesses of scale that really have a global role to play, and so I encourage those who are already doing so to encourage others to do the same as a way of giving back.
Mark Bamforth is the founder and President & CEO of Arranta Bio, which was established in May 2019. In 2015, Mr. Bamforth founded Brammer Bio, a viral vector CDMO supporting cell and gene therapy companies, which was acquired by Thermo Fisher Scientific in April 2019. In 2010, Mr. Bamforth founded Gallus BioPharmaceuticals, a CDMO supplying biopharmaceuticals. In September 2014, Gallus was sold to DPx Holdings B.V., which later became part of Thermo Fisher Scientific. He holds a bachelor’s degree in chemical engineering from Strathclyde University and an MBA from Henley Management College.