The FDA and the pharma industry have taken note as the nutrition industry has promoted gut bacteria for preventing disease. Now, Swiss CDMO Lonza is getting in with a joint venture that will feed the industry with live biotherapeutic products for trials and development of FDA-approved products.
Lonza today said it is forming a €90 million, 50/50 JV with Denmark’s Chr. Hansen in hopes of becoming the go-to CDMO for LBPs. The two claim the JV will be the first CDMO globally to provide a full supply chain to manufacture bacteria strains for that kind of therapeutic use.
"We need to think differently about how we develop solutions for manufacturing in the microbiome space as we see the potential of this therapeutic area develop,” Lonza Group CEO Marc Funk said in a statement. “By teaming up with Chr. Hansen, one of the world’s largest producers of bacteria, we are combining expertise that perfectly fits the very specific needs of aspirational companies in the microbiome space.”
Mauricio Graber, CEO of Chr. Hansen, said the JV is a way for the company to utilize its 145 years of experience in strain development and manufacturing and be in “the highly attractive LBP industry whilst sticking to our strategy of not becoming a fully-fledged pharma company.”
They said the market value of supplying clinical and commercial supplies for the industry should reach €1 billion by 2025.
The investment for the JV, which is to be shared equally, will be phased in over three years to build compliant production facilities. They will start by investing €45 million to upgrade existing facilities in Hørsholm, Denmark, and equip new facilities in Basel, Switzerland, to handle preclinical to phase 2 projects. Another €45 million will be invested in commercial production capabilities if customers reach those targets.
Anticipating the industry, the FDA several years ago published (PDF) CMC guidance for producing material for early clinical trials with LBPs. While the agency has yet to approve a probiotic as an LBP, it held a workshop in September on the subject.
It noted that while consumers have been hearing about the potential benefits of so-called “good bacteria,” there needs to be more research about both benefits and risks. The agency explained the workshop was one piece of a broader effort to play a “key role in sorting through the science and the science fiction of this evolving field."