Lonza and the Danish food cultures and enzymes producer Chr. Hansen have formed a joint venture to make live therapeutic microbes for the nascent microbiome drugs sector. It is the first and only company in the world to offer end-to-end contract manufacturing services for live biotherapeutics, Lonza CEO Marc Funk says.
Clinical trials of microbes are already underway
Phase 1: 20
Phase 2: 11
Phase 3: 5
By 2025 the contract manufacturing market for the microbiome is forecast to be worth $200 million
Some of the microbes populating the intestine, which constitute the bulk of the human microbiome, may have therapeutic effects and could be used to treat gastrointestinal diseases as well as some cancers, liver diseases, and more.
No such drugs are yet on the market, but by 2025 the supply of anaerobic microbes for pharmaceutical trials will be worth about $200 million annually, Funk says. By 2035, he forecasts, the overall clinical trial and commercial market will be worth more than $1.1 billion.
Initially, the partners will put a combined $50 million in the joint venture to meet demand from pre-commercial projects. Starting in about 2022, they will invest a further $50 million to expand capacity to make commercial microbial drugs.
The venture will start out with a staff of 50, 10 of whom will come from partners, rising to about 120 from 2022.
Chr. Hansen’s role in the venture will be to evaluate microbe strains and produce them in its fermenters near Copenhagen. Lonza will formulate the microbes and place them in capsules at its facilities in Basel, Switzerland, where the venture will also be based.
Lonza says the venture will use the enTRinsic capsule technology developed by Capsugel, a firm it acquired in 2017. It features a structural mesh inside a polymer shell that protects the microbes from acids in the stomach and ensures reliable release in the intestine.
The microbiome initiative is part of a broader trend for contract manufacturers to pursue emerging classes of biological drugs, such as those used in gene therapy. Thermo Fisher Scientific recently entered the business of making viral vectors for gene therapy by acquiring Brammer Bio for $1.7 billion.