Lonza JV to produce live biotherapeutic products for gut bacteria field
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."
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