Boston is one of the top global hubs for biotechnology companies developing live biotherapeutic products (LBPs), and many of these companies seek out the expertise of the world leading CDMO, France’s Biose Industrie. As of September, 2020, Biose Industrie’s manufacturing expertise will be even closer to these US organizations: the company has established a new office in Boston, USA. The office, which officially opened September 1st, will help Biose Industrie fully and flexibly support its many US-based clients.
Adrien Nivoliez,PhD, CEO at Biose Industrie, says the US expansion was a natural progression for the company at this stage in the development of the industry, since several US-based companies are completing Phase 2 and even Phase 3 clinical trials for their drug products. He says,
“Many of Biose Industrie’s US clients are advancing their clinical programs quite quickly and need to address their unique manufacturing challenges. Whether they are in the early stages of process development or further down the line our new office allows us to respond to their needs and give them the high-quality support they have come to expect from us.”
Richard Ellis, Business Development Director who’s responsible for business development globally, adds,
“Boston is so important for the microbiome space because alot of the leading LBP companies are headquartered there. This move is strategic for us, so we can maintain our close relationship with the companies that are closest to bringing LBPs to market.”
Leading with scientific knowledge
The new office is led by Laurent Bouillaut, PhD, a 13-year resident of Boston who held previous roles in Clinical, diagnostic and process development for LBPs. Having already worked for several companies concerned with microbiomes—of the gut and of the skin—he brings a good grasp of the ideas, challenges, and existing projects in this scientific field.
Bouillaut’s previous experience as a microbiologist focused on isolating, fermenting and manufacturing live microbes, is serving him well in a role that requires both scientific knowledge and a penchant for innovation. “In the past, I worked with anaerobic bacteria in the gut, which were notoriously difficult to grow,” he says.
“My experience in Clostridium fermentation gave me an appreciation for the scientific challenges that can arise, and how to think ‘outside the box’ to solve problems.”
In taking on the role of Project and Business Manager for Biose Industrie’s new office, Bouillaut says,
“The Biose Industrie team is strong on scientific qualifications. I’m happy to join this group and work closely with colleagues in France to problem-solve on different projects.”
Keeping pace with a growing industry
Bouillaut says that while Biose Industrie will continue to do its large-scale manufacturing in France whilst aiming to expand their capabilities in Boston.
In a few years’ time, the company could see a US-based manufacturing capacity that accommodates clinical trials up to Phase 1 and Phase 2.
“We already have one foot in the US market, and I’d like to make sure we put in both feet,”
“Our activities here can be very responsive to what our US clients need.”
Meeting global challenges
Bouillaut says the plans for a Boston office existed long before the COVID-19 pandemic hit, but it’s especially critical to have someone in the US during this period of restricted activities. Bouillaut says,
“Since COVID-19 pandemic began, travel between the US and France has not been as easy. Having this office established on US soil helps us stay more connected to our US clients and respond flexibly to their needs.”
COVID-19 has not significantly slowed down Biose Industrie’s overall business, since the biotechnology companies developing LBPs are more driven than ever to demonstrate the efficacy of their products and bring them to market.
“So far, our large facility in France has been operating safely at 100% capacity,” Bouillaut says. “Things are running well, and this office in Boston helps us make the France-US connection as smooth as possible. With good communication, we’re able to face the challenges of this global situation we’re all dealing with.”
Regulatory challenges also exist in the field of LBPs, but the company has a plan for meeting those as well. Biose Industrie’s manufacturing practices (GMP) and facilities already pass muster with the European regulatory agencies, and the company is also making good progress toward its goal of becoming FDA approved.
“We are working with our US clients and with the FDA to make sure everything is very well aligned, and we’re on our way to FDA approval in the next couple of years.”
Through all of this, he says, it’s exciting to help Biose Industrie’s clients bring live biotherapeutic products closer to the market and to the patients who need them.
“The industry is growing quickly. Every week brings some new data or milestone that shows progress in this space, and we are proud to be on the forefront.”