Live Biotherapeutic Products

Market Trends

The microbiome is increasingly a foundation for new therapies in dermatology, endocrinology, cancer, central nervous system and cardiovascular indications. Biopharma companies are developing Live Biotherapeutic Products (LPB)1 that aim to restore microbiome populations missing in disease or remove harmful ones. There are currently around 100 LPB therapies in the clinical pipeline with five nearing commercial launch. However, most of these are small companies with limited specialized in-house manufacturing capabilities.

The biggest challenges facing companies developing LPB are the difficulty of identifying and growing strict anaerobic bacteria, or cocktails of bacteria, and then maintaining anaerobic conditions in an oral dosage form that delivers the bacteria to the intestine.

1 A Live Biotherapeutic Product is a biological product that contains live organisms, such as bacteria and that is applicable to the prevention, treatment or cure of a disease or condition of human beings (excludes vaccines)

Establishing an Offering in 2019

In 2019, a 50/50 strategic joint-venture (JV), was established between Lonza and Danish company Chr. Hansen for developing and manufacturing live biotherapeutic products for pharma and biotech customers. The JV got approval to start operations under the name BacThera.

While Chr. Hansen contributes its know-how in developing, upscaling and manufacturing bacteria strains, we bring capabilities in pharma contract manufacturing and formulation and drug delivery technologies, including the enTRinsicTM capsules.
 

BacThera Offerings Overview
STAGE 1: 2019–2022 Development services

Approx €45 million shared investment

~50 staff initially

  • Serving start-up and small biotech with pre-clinical & clinical development projects
  • Service offering focused on process development and small batches
STAGE 2: 2022 Phase III & commercial batch services

Approx €45 million shared investment*

~120 staff

  • Serving a mixture of biotechs and their acquirers (e.g. large pharmacos) as clinical projects commercialize
  • Service offering expanding to large batch sizes for Phase III and commercial production

* based on customer demand

Our Global Footprint

BacThera will operate from its headquarters in Basel (CH). In addition, the JV will upgrade existing facilities in Hørsholm (DK), and equip new facilities in Basel to serve pre-clinical to Phase II projects. Further facilities will be developed as the pipeline matures.

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