Basel, Switzerland and Hørsholm, Denmark, 31 May 2021 – 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, 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,”
About Live Biotherapeutic Products:
Live Biotherapeutic Products, LBPs for short or more popularly known as bugs-as-drug, are a new therapeutic modality being developed by a range of biotech and pharma companies across the world. LBPs are unique because their active substance is a living organism, most commonly a bacterium, that has been identified as showing promise in treating one or sometimes several diseases. LBPs are diverse and can consist of e.g. a single organism, a genetically modified organism, or a consortium of organisms.
Bacthera was founded end of 2019 as a 50:50 Joint Venture of the two companies Chr. Hansen A/S and Lonza AG to specifically serve the needs of the emerging Live Biotherapeutic Product industry. Overall, EUR 90 million will be invested, shared equally between Chr. Hansen and Lonza.
Bacthera’s expertise and the capabilities of production of bacteria for pharmaceutical purposes were transferred by both parent companies to Bacthera right from the beginning.
Bacthera offer a compelling set of services across the LBP life cycle and process chain, from technical R&D development right through to cGMP manufacture and QC testing of drug substance and drug product.
Bacthera operates from its Headquarter and Center of Excellence for drug product process development and manufacturing, and QC analytical testing in Basel, CH, and its Center of Excellence for drug substance process development, analytical development, and manufacturing in Hørsholm, DK.
Follow @Bacthera on LinkedIn
Follow @BactheraAG on Twitter
Lonza is the preferred global partner to the pharmaceutical, biotech and nutrition markets. We work to prevent illness and enable a healthier world by supporting our customers to deliver new and innovative medicines that help treat a wide range of diseases. We achieve this by combining technological insight with world-class manufacturing, scientific expertise and process excellence. These enable our customers to commercialize their discoveries and innovations in the healthcare sector.
Founded in 1897 in the Swiss Alps, today Lonza operates across five continents. With approximately 14,000 full-time employees, we are built from high-performing teams and of individual talent who make a meaningful difference to our own business, as well as to the communities in which we operate. The company generated sales of CHF 4.5 billion in 2020 with a CORE EBITDA of CHF 1.4 billion. Find out more at www.lonza.com.
Follow @Lonza on LinkedIn
Follow @LonzaGroup on Twitter
About Chr. Hansen
Chr. Hansen is a leading, global bioscience company that develops natural ingredient solutions for the
food, nutritional, pharmaceutical and agricultural industries. We develop and produce cultures, enzymes, probiotics and natural colors for a rich variety of foods, confectionery, beverages, dietary supplements and even animal feed and plant protection. Our product innovation is based on more than 30,000 microbial strains – we like to refer to them as ‘good bacteria’. Our solutions enable food manufacturers to produce more with less – while also reducing the use of chemicals and other synthetic additives – which make our products highly relevant in today’s world. Sustainability is an integral part of Chr. Hansen’s vision to improve food and health. In 2019 Chr. Hansen was ranked as the world’s most sustainable company by Corporate Knights thanks to our strong sustainability efforts and our many collaborative partnerships with our customers. We have been delivering value to our partners – and, ultimately, end consumers worldwide – for over 140 years. We are proud that more than one billion people consume products containing our natural ingredients every day.
Bacthera Contact Details
Lonza Contact Details
Head of External Communications
Lonza Group Ltd
Tel +41 61 316 2283
Lonza Group Ltd
Tel +41 61 316 8540
Chr. Hansen Contact Details
Director, Head of Media Relations
Tel +45 60 38 62 07
Additional Information and Disclaimer
Lonza Group Ltd has its headquarters in Basel, Switzerland, and is listed on the SIX Swiss Exchange. It has a secondary listing on the Singapore Exchange Securities Trading Limited (“SGX-ST”). Lonza Group Ltd is not subject to the SGX-ST’s continuing listing requirements but remains subject to Rules 217 and 751 of the SGX-ST Listing Manual.
Certain matters discussed in this news release may constitute forward-looking statements. These statements are based on current expectations and estimates of Lonza Group Ltd, although Lonza Group Ltd can give no assurance that these expectations and estimates will be achieved. Investors are cautioned that all forward-looking statements involve risks and uncertainty and are qualified in their entirety. The actual results may differ materially in the future from the forward-looking statements included in this news release due to various factors. Furthermore, except as otherwise required by law, Lonza Group Ltd disclaims any intention or obligation to update the statements contained in this news release.