Bacthera Receives Manufacturing Licenses in Switzerland and Denmark

Following 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 Hørsholm, Denmark, both facilities have been granted manufacturing licenses by the respective national health authorities.

This milestone means Bacthera AG, a specialist contract development and manufacturing organization (CDMO), is ready to supply customers with medicines from one of the world's most advanced pharma manufacturing supply chains for live biotherapeutic products (LBP), a new therapeutic class based on live microbes.

"These licenses have been a key milestone to reach since the founding of Bacthera. It greatly excites me that we can now supply our customers with LBP medicines for clinical trials in humans and ultimately also commercial products. I am very proud of what our team has achieved," states CEO Lukas Schüpbach, Bacthera.

"The manufacturing license is an important milestone for our microbiome lighthouse and a crucial enabler for the emerging LBP industry. We are very pleased that Bacthera can now truly start realizing its vision and business model to become a world-leading CDMO in this emerging field," says CEO Mauricio Graber, Chr. Hansen.

"The addressable market for clinical and commercial supply long-term has the potential to exceed EUR 1 billion. 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," adds Jean-Christophe Hyvert, President, Division Head Biologics, Cell and Gene, Lonza.

"Bacthera's ambition is to enable our customers to bring life-changing treatments to patients by pioneering the LBP industry. We find it very rewarding to be treading on virgin territory together with our customers in the microbiome space," concludes Schüpbach.