Bacthera secures double nod to tread on "virgin territory"

The specialist CDMO receives manufacturing licenses from Switzerland and Denmark to supply customers with live biotherapeutic medicines

Swissmedic passed Bacthera's drug product facility in Basel, whereas the Danish Medicines Agency approved the CDMO's drug substance facility in Hørsholm.

These licenses represent Bacthera's readiness to supply customers with medicines from a particularly advanced pharma manufacturing supply chain for live biotherapeutic products (LBP), or 'bugs-as-drugs', a new therapeutic class based on live microbes.

“The manufacturing license is an important milestone for our microbiome lighthouse and a crucial enabler for the emerging LBP industry," said Mauricio Graber, CEO, Chr. Hansen.

According to Jean-Christophe Hyvert, President, Division Head Biologics, Cell and Gene, Lonza, the market for long-term clinical and commercial supply could exceed EUR 1 billion.

"With a growing pipeline of microbiome-targeting therapies, gaining the manufacturing license represents a significant milestone for Bacthera," said Hyvert.

CEO Lukas Schüpbach, Bacthera, described working with customers in this emerging field as "treading on virgin territory".

The medicines will be manufactured initially for in-human clinical trials, with the hope of later producing commercial products.