Chr. Hansen and Lonza JV reaches “key milestone” to manufacture live biotherapeutic products

31 May 2021 --- Chr. Hansen and Lonza’s joint venture, Bacthera, is now ready to start supplying live biotherapeutic products (LBP) following Swiss and Danish manufacturing licenses. The new therapeutic class is based on live microbes that can address patients with “unmet medical needs.”

“The products and technologies that Bacthera offers to its customers are world-class development and manufacturing technologies for LBPs. We are an end-to-end contract development and manufacturing organization (CDMO), meaning that we cover their entire LBP development and manufacturing process horizontally and vertically,” Felix Faupel, chief commercial officer at Bacthera, tells NutritionInsight.

“These licenses have been a key milestone to reach since the founding of Bacthera. We can now supply our customers with LBP medicines for clinical trials in humans and ultimately commercial products,” adds Lukas Schüpbach, Bacthera’s CEO.

The manufacturing licenses were granted after good manufacturing practices (GMP) inspections by Swissmedic at Bacthera’s drug product facility in Basel, Switzerland, and by the Danish Medicines Agency at Bacthera’s drug substance facility in Hoersholm, Denmark.

A look toward the future
Bacthera already has customers in different world geographies. “For confidentiality reasons, we are not able to share our customers’ names, but they range from small start-ups, via mid-sized biotechs to large pharma,” says Faupel. 

As Bacthera is operating in a relatively novel and young industry, turnaround times differ from project to project, customer expectations and also project endpoints. 

Most of the projects are still in early phase development or in phase one, but Faupel sees the first business finalizing their pivotal phase 3 studies. Generally speaking, the LBP industry can expect the first commercial product to come to the market (probably in the US) within the next few years, he says. 

“Our ambition is to de-risk the Chemistry, Manufacturing and Control (CMC)) development of our customers’ projects and to fast-track their products to the market, by establishing scalable and efficient production processes already early on.”

Exploring “virgin territory”
The addressable market for clinical and commercial supply long-term has the potential to exceed €1 billion (US$1.2 billion), according to Jean-Christophe Hyvert, president, division head biologics, cell and gene at Lonza. 

“With a growing pipeline of microbiome-targeting therapies, gaining the manufacturing license represents a significant milestone for Bacthera. The license will allow the company to fulfill the scope of bringing innovative live biotherapeutic products to patients with unmet medical needs,” he continues. 

Schüpbach adds: “We find it very rewarding to be treading on virgin territory together with our customers in the microbiome space.” 

Faupel further elaborates that the LBP space is virgin territory because no LBP is on the market yet. Additionally, comparable services to what Bacthera offers to the LBP industry are “quite limited.”

Bacthera was first announced in 2019. At the time, Bacthera said it would attract €90 million (US$110 million) in investment from Lonza and Chr. Hansen over the next three years.Bacthera can now supply its customers with LBP medicines for clinical trials in humans.

Introducing The Probiotics Institute
Chr. Hansen also launched both a global and Chinese version of The Probiotics Institute today in a bid to help combat misconceptions about probiotics and their benefits.

The platform provides educational and scientific content on probiotics and the human microbiome to healthcare professionals and B2B customers on a global scale. Other subjects detailed by the institute will include infant health and immunity.

“Consumers, as well as health care professionals, really want to understand more about probiotics. There are so many questions, like are all probiotics the same and are more strains better,” Linda Neckmar, vice president of commercial development at Chr. Hansen, tells NutritionInsight in an exclusive video interview. 

“We have a strategic ambition to shape the global probiotics market through scientific leadership and expansion into new B2B customer groups and segments, and this initiative should be seen as a step in that direction,” adds Christian Barker, executive vice president of Chr. Hansen’s health and nutrition division.”

The company hopes that The Probiotics Institute will foster the engagement of users and become a natural forum of reference and interaction for health care professionals and professional science communities.The Probiotics Institute by Chr. Hansen is a global online platform aiming to educate people about probiotics and the human microbiome.

Targeting the Chinese market
The Probiotics Institute was first launched in April 2020 for the US audience. At the time, Anne-Christina Hoff, head of human health global marketing at Chr. Hansen, told NutritionInsight that the US institute was designed for two levels of understanding – for health care professionals and for the general public, enabling visitors to choose the relevant level.

The new global version is currently available in English, with further languages set to come. Additionally, Chr. Hansen is also launching The Probiotics Institute (China), a service in Chinese specifically designed to match the needs of the Chinese market only.

Also, a locally hosted version of Chr. Hansen’s official website in Chinese is underway with an expected launch during June. A local Chinese server hosting the corporate website will make it easier for Chinese stakeholders to access the information on the website considerably faster and more smoothly.

Last month, Chr. Hansen spotlighted the potential of the Asia-Pacific (APAC) market in its Q2 2020/2021 results, especially amid changing regulations around human milk oligosaccharides. 

By Katherine Durrell