Brammer Biopharmaceuticals recently merged with Florida Biologix to create a cell and gene therapy biologics contract development and manufacturing organization (CDMO). The merged company, Brammer Bio, is set up to combine technical expertise in process development and clinical manufacturing with capabilities, operating approaches and quality standards required for commercial manufacturing.

Brammer Bio is focused on providing clinical and commercial supply of autologous and allogeneic cell therapies, and viral vector products for in vivo and ex vivo therapeutic applications, along with process and analytical development, and regulatory support enabling large pharma and biotech clients to accelerate the delivery of novel medicines.

Brammer Bio occupies 45,000 sq.-ft. of process development and Phase I/II clinical manufacturing space in Alachua, FL, and is developing a 50,000 sq.-ft. facility in Lexington, MA, with plans to build-out large-scale, Phase III/commercial ready viral vector manufacturing suites, segregated cell and gene therapy suites, and QC and analytical laboratories for clinical and commercial launch services.

The management team is led by Mark Bamforth, president and chief executive officer, and Steven Kasok, chief financial officer. The two were previously co-founders of Gallus Biopharmaceuticals. Richard Snyder, chief science officer, is the founder of Florida Biologix, which was spun out of the University of Florida in 2015. Contract Pharma talked with Mr. Bamforth about the two companies coming together as well as cell and gene therapy market trends.       —Tim Wright

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Contract Pharma: What led to the merger agreement and what does each side bring to the table?
Mark Bamforth: Well, during my 22 years with Genzyme Corporation, the last 10 based in Massachusetts running global manufacturing, I had responsibility for what ended up being about a dozen main manufacturing sites in the U.S. and Europe. We were covering most technologies including cell therapy and gene therapy. Genzyme was a pioneer in this space. I left in 2010 and set up a contract manufacturing business called Gallus Biopharmaceuticals and we acquired a site in St. Louis and were focused on mammalian cell culture-based products, mainly monoclonal antibodies and enzymes.

When Gallus was acquired in September 2014 by Patheon, I stayed for a number of months to support the integration and then early last year I started to develop plans for a new business, Brammer Biopharmaceuticals, with my partner, Steve Kasok, who also partnered with me on Gallus. We identified a site in Massachusetts and also some other opportunities to acquire an existing business. The idea was that we’d combine this existing business with having a site in Massachusetts where many of the cell and gene therapy companies are, allowing us to leverage the experience and procedures and the client base and relationships of the existing business to help build the new site in Massachusetts.

For various reasons plans were delayed. It’d been close to a year and I was reintroduced to the team at Ampersand Capital, who had made an investment in Florida Biologix in November 2015 to help spin that business out of the University of Florida. What they had in hand was fascinating because, basically Florida Biologix had been in business for a decade, had a good client base and an outstanding technical reputation in the industry for process development and early clinical supplies for viral vectors used in gene therapy. They had also done some cell therapy work but their main focus was in gene therapy. They also had some clients who at that point were starting to plan for their Phase III manufacturing, but their facility in Florida wasn’t set up to handle Phase III projects.

They developed plans to build capacity but they also recognized they would have to build an organization that was capable of running Phase III and commercial products. These plans were in the works when I was introduced to Ampersand we realized quickly that the plans Brammer had developed dovetailed very well with Florida Biologix. As we examined it we realized that putting the two businesses together made a lot of sense because we could use the plant in Massachusetts to establish Phase III and commercial manufacturing for larger volumes of viral vectors for gene therapy. We could also build out some cell therapy space in Massachusetts that had been squeezed out because of demand in Florida, which would then allow us to double the capacity in Florida for earlier stage clients because the capacity today is maxed out. It’s a great position to be in on one hand but on the other hand you want to be able to take on new clients and be able to support them.

CP: Any future growth plans?
Bamforth: We have a lot of space for organic growth. The team in Florida is composed of about 120 people and we see that growing to somewhere between 150-200 people. The site in Massachusetts is a very similar size to the Florida location, around 50,000 square feet, and will also employ around 150-200 people.

Initially we intend to double the process development and early-clinical capacity at the Florida location. Existing and future clients taking their gene and cell therapy projects to Phase III and beyond will be supported at the Lexington, MA facility. So there are two distinct areas of focus. Early stage process development and clinical manufacturing will be handled down in Florida. If molecules survive through the clinical process and we need to scale up and go to phase III manufacturing and prepare for licensure we’ll do that work in Massachusetts. The two activities will remain separate but with a strong connection between them.

In addition to organic growth plans, we’re also alert to opportunities to consider M&A or partnering with other organizations. We did a number of technology partnerships in my last company, which we found to be a very effective way of accessing new technology as well as working with technology partners who may have done process development for clients and are looking for a CDMO who could help make clinical material for them.

CP: What are the current trends, opportunities and challenges in the cell and gene therapy market?
Bamforth: There are very few gene therapy products anywhere in the world. Only a couple have been approved and none in the U.S. There are a number of cell therapy products out there and Genzyme, who I worked for, is a pinoneer in this space. They launched the first product back in the late 1990s. There’s about $1.5-2 billion worth of cell therapy end product sales, which sounds like a big number, but not when you compare it to the roughly $140 billion worth of biological products out there.
When thinking about the cell and gene therapy market, the key thing to remember is that there is a very rich pipeline of over 500 cell and gene therapies in the clinic, and many of the large and specialist biotech companies pursuing these promising treatments want to leverage the expertise of a reliable, high-quality CDMO to supply their products for clinical through to commercial use. Through this merger Brammer now has the necessary laboratory and production capabilities and a highly skilled team of scientists with the development, manufacturing and analytical expertise required to tackle the challenges posed by these novel technologies and help accelerate their transition from the clinic to patients in need.

CP: How much is being invested in cell and gene therapy?
Bamforth: Roughly $5 billion has been invested in gene therapy R&D so far and the companies operating in the space are either small specialists or they’re large pharma/biopharma. In fact, most of the large companies now have gene therapy programs. Those companies sometimes handle process development internally, but many of them are collaborating with the smaller companies and few of them have committed to their own manufacturing at this point. So this is why there is a very good opportunity to build a world-class CDMO to support the growth of this industry and really the maturing of it.

CP: What is the projected market size?
Bamforth: There are various estimates for market size but around $10 billion by 2020 is in the range of what people are estimating. Over the past decade there has been a tremendous amount of research going on and it’s been in the last five years, and certainly the last two years, this has started to mature very rapidly. If you look at the disease areas that people are looking into with gene therapy, it’s moving from rare, niche diseases to things like Parkinson’s disease and other major diseases. The idea is that we might be able to cure these diseases by fixing the genetic error that is the cause of the disease. The market is following a natural cycle when you factor in how long it takes to really gain knowledge and understanding and the ability to predictably and safely deliver a product that’s going to help patients.