Manufacturing and the microbiome: Lonza, Chr. Hansen set out to pioneer the live biotherapeutic products industry
The global bioscience company Chr. Hansen Holding A/S, and contract development and manufacturing organization (CDMO) Lonza AG will equally share approximately €90m ($101.5m) over three years to establish a contract development and manufacturing organization (CDMO) for biotherapeutic products.
The joint venture (JV) aims to “pioneer” the live biotherapeutic products (LBPs) industry and was formed in response to a “clear need for an end-to-end solution for manufacturing” in the LBPs area, said Lonza Group CEO Marc Funk.
“We had the drug product part of the equation with the formulation and capsule technology, and also the experience in cGMP [current good manufacturing practice] manufacturing, but not the anaerobic microbial manufacturing capacity,” explained Funk. “So, we looked to see who we could partner with to bring the anaerobic fermentation part of the equation and Chr. Hansen was the obvious choice.”
The investment, which will take place in two phases, will begin with an update to Lonza’s existing facilities in Hørsholm, Denmark for cGMP production of drug substance (anaerobic bacteria). It also will equip new facilities in Basel, Switzerland for drug product development and manufacturing.
Funk said, “Initially the service offering is focused on process development and small batches to serve start-ups and small biotech with preclinical and clinical development projects.”
Phase two of the investment will see new facilities for Phase III and commercial manufacturing “as the pipeline matures,” he explained.
The companies expect the venture to be largely self-funding after the production set-up has been established.
Manufacturing and the microbiome
Manufacturing strict anaerobes is challenging, said Funk, and requires “specialized assets and know-how which are not as widespread in the biopharma space.”
However, looking outside biopharma, the food industry has established anaerobic fermentation, though not under cGMP conditions, he explained.
“This partnership that brings the best of the food industry’s know-how and technology, together with pharma manufacturing expertise with its stringent quality and regulatory systems, is an ideal solution in the live biotherapeutic products space.”
According to Funk, there are several drivers of the demand for LBPs – the pipeline of which is healthy, with the first products approaching commercialization.
This demand is due in part to high throughput screening and microbiome libraries, which have progressed science by easing the identification process of possible therapeutic strains.
While gastrointestinal (GI) tract indications have until now been the main focus, Funk noted other areas of research, including oncology and possibly neurodegenerative diseases, as the understanding of the gut-brain axis advances.
“There are unmet medical needs that so far cannot be addressed with ‘conventional’ large and small molecule therapies and biotherapeutics could make a positive difference,” he said.
Based on the number of ongoing trials up to Phase III, the global clinical supply industry is estimated to reach €150-200m by 2025, according to Lonza. Including the commercial supply industry in this estimate, the market is predicted to exceed €1bn by 2035.
“The funding is good,” said Funk, “and growing as the number of companies in this space grows. The success of current Phase III projects will have a bearing on this going forward.”
