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The companies form a strategic joint venture for developing and manufacturing live biotherapeutics.
On April 2, 2019, Lonza and Chr. Hansen Holding, a global bioscience company entered into an agreement to establish a 50/50 joint venture to pioneer live biotherapeutic products (LBPs) and position themselves as the leading contract development and manufacturing partner (CDMO) for biotech and pharma customers. The joint venture will operate from headquarters in Basel, Switzerland, and have production facilities in Denmark and Switzerland.
Under the agreement, a phased investment of approximately EUR 90 million (US$101 million) will be shared equally between the parties over a period of three years and will be deployed to build cGMP-compliant pharma production capabilities. The joint venture will upgrade existing facilities in Hørsholm, Denmark, and equip new facilities in Basel to serve pre-clinical 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 (US$50 million) will be spent initially and an additional EUR 45 million (US$50 million) will be spent 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.
The joint venture will combine complementary capabilities and will be the first CDMO globally to provide a full supply chain that offers manufacturing of bacteria strains for therapeutic use, according to the companies. Chr. Hansen will contribute its extensive know-how in developing, upscaling, and manufacturing bacteria strains, and Lonza will brings its strong capabilities in pharma contract manufacturing and formulation and drug delivery technologies, including enTRinsic capsules.
The joint venture will also possess leading competences in handling, characterizing, formulating, manufacturing, and encapsulating strict anaerobe bacteria. These competences will be housed under one roof, with seamless exchanges between drug substance and drug product activities, which is expected to decrease development timelines and increase the chance of “right-first-time.” It will target the emerging pre-clinical and clinical supply industry for LBP with a large upside to serve the ensuing commercial demand, once the first live biotherapeutic products are approved and available for treatment.
"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,” said Marc Funk, CEO, Lonza Group, in a company press release. “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.”
“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 145 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 bacteria-based medical products enter the commercial market,” said Mauricio Graber, CEO of Chr. Hansen, in the release.