Chr. Hansen Holding A/S, a leading global bioscience company, and Lonza AG, a leading pharma contract manufacturing company, have signed an agreement to establish a 50/50 joint venture to pioneer the live biotherapeutic products (LBP) industry and position themselves as the leading contract development and manufacturing partner (CDMO) for biotech and pharma customers. The joint venture will be a 50/50 controlled legal entity which will operate from its headquarters in Basel, Switzerland and have production facilities in Denmark and Switzerland.
The joint venture brings together best-in-class, complementary capabilities and will be the first CDMO globally to provide a full supply chain that offers manufacturing of bacterial strains for therapeutic use. Whilst Chr. Hansen contributes its extensive know-how in developing, upscaling and manufacturing bacterial strains, Lonza brings strong capabilities in pharma contract manufacturing and outstanding drug delivery technologies. Furthermore, the joint venture will possess leading competences in handling, characterizing, formulating, manufacturing and encapsulating strict anaerobe bacteria. These competences under one roof, with seamless exchanges between drug substance and drug product activities will decrease development timelines and increase chance of ‘right-first-time’.
“The joint venture is a quantum leap for Chr. Hansen’s human microbiome lighthouse. It’s a great opportunity to utilize our microbial capabilities in the highly attractive LBP industry whilst sticking to our strategy of not becoming a fully-fledged pharma company. Chr. Hansen has more than 120 years of experience in strain development and manufacturing and we are really thrilled to join forces with a leading global company in the pharma CDMO market to become the partner of choice for end-to-end biotherapeutic solutions. The clinical trial supply industry is a rapidly emerging field, not to speak of the very large potential when the first bacteriabased medical products enter the commercial market,” says Mauricio Graber, CEO of Chr. Hansen.
"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. 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. Our customers will be able to draw on the unrivalled skillset of two world experts that master the exacting processes required for production of strict anaerobic microbes through to formulation and dosage forms. We understand the complexities of bringing pharmaceuticals to market, including the evolving regulatory environment, and will offer unique development and pharma-grade manufacturing that addresses an unmet need in the industry, enabling customers to deliver therapies for patients,” says Mark Funk, CEO, Lonza Group.
The ability to find ways to deliver anaerobic microbes in therapeutics is important since many findings point to the importance of anaerobic bacteria in healthy microbiomes. However some of these bacteria are easily killed or at least do not grow when exposed to oxygen.
The phased investment of EUR 90 million will be shared equally between the parties over a period of three years and will be deployed to build cGMP2 -compliant pharma production capabilities. The joint venture will upgrade existing facilities in Hørsholm, Denmark, and equip new facilities in Basel, Switzerland to serve preclinical to phase II projects. Further facilities for phase III and commercial manufacturing will be developed as the pipeline matures. Investments follow a stage-gate-process with clearly defined targets. EUR 45 million will be spent initially and additional EUR 45 million once customer demand for clinical phase III and commercial supply is confirmed. The joint venture is expected to be largely self-funding after the production set-up has been established.