Serving an Accelerated Market with mRNA Production

Serving an Accelerated Market with mRNA Production

Dec 08, 2021PAO-11-21-CL-06

Arranta Bio Founder, Executive Chairman, and CEO Mark Bamforth describes the future of the company and what solidified the decision to expand into mRNA manufacturing, as well as what to expect next from this rapidly advancing platform.

David Alvaro (DA): Can you tell us how Arranta Bio is evolving and what the future holds for the company?

Mark Bamforth (MB): Arranta Bio started with one main platform to support microbiome clients. Around the same time, we partnered with Thermo Fisher Scientific to supply them with plasmids for cell and gene therapy clients, and today we’re announcing that we’re adding a third platform for messenger RNA manufacturing. These three platforms are highly complex products to manufacture. With the microbiome, we’re continuing to see growth in this market. There are some clinical challenges, which is not unusual for new areas, but there’s a lot of progress being made in developing products to support patients that have an infectious disease, inflammatory diseases, or neurological diseases that are linked to the gut. The performance of oncology treatments is also inextricably linked to gut health and the immune system.

As I mentioned, we’re partnered with Thermo Fisher to supply them with plasmids, which they provide to clients for both cell and gene therapy — and those same kinds of plasmids are also used as the starting material for messenger RNA. We’re also pleased to announce that we’re moving into mRNA manufacturing, beginning with the raw materials, through the mRNA synthesis itself, and then to the formulation and the lipid nanoparticle, and finally to the aseptic filling.

DA: What drove the decision to move into the mRNA space?

MB: The incredible performance of the COVID-19 vaccines developed using mRNA at Pfizer/BioNTech and Moderna has been very public, though six months ago we began conversations with select companies about their supply needs in this arena. While we’ve observed and experienced the phenomenal uses with mRNA for large populations affected by infectious diseases first-hand, there are many other uses for this technology, and there are already ongoing clinical trials using mRNA to trigger the body to attack different cancers. This is an area that’s been in development for about 20 years, but there haven’t yet been any approvals for these products. Now that a proof-of-concept from the COVID-19 vaccines exists, I think it’s very clear that there’s going to be an acceleration of development in this space, and we’re ideally suited to support companies interested in creating drugs based on mRNA technology.

We’ve built a facility here in Watertown, Massachusetts, which is about 80,000 square feet, to service the market. We have numerous laboratories that can support the development work, and we have clean rooms that are ready and built to the standards necessary to support the manufacture of these complex products. We’re also in a fortunate position, because we have many team members with experience in mRNA, in the design of the facilities, the layout of the processes, and in manufacturing.

DA: In your view, what makes a partnership with Arranta Bio so special?

MB: We work for a variety of clients, some of which expect a transactional relationship — for instance, we’ll make a batch of product and deliver it to them to use as they will. However, many more are seeking a deeper collaborative partnership. In this case, Arranta Bio provides an essential service to them, be it a dedication of space, whether it’s a laboratory or it’s a clean room, a team to support their needs; and, ultimately, the delivery of what they need. By having so much expertise in-house, we can solve problems for our clients and become a critical part of their success story.

DA: How will existing clients who are working with Arranta Bio on live biotherapeutic product programs be impacted by the company’s entry into the mRNA space?

MB: The short answer is that they won’t be impacted by this. We have a number of clients already, including several in phase III for microbiome products, and we’ll continue to serve those clients. We have dedicated laboratories to support their needs, and we have separate laboratories and clean rooms that we can use for mRNA. We also announced back in March of 2021 that we had leased space in Boxborough, Massachusetts, which is a very large facility, at about 130,000 square feet. We have the first modules — actual mobile units that are being moved into that facility by the end of this year, and we expect that to come online next year. We have plenty of space to continue to serve our clients in the live biotherapeutics products/microbiome and mRNA spaces and beyond.