LMPs: Therapeutic Bacteria

They float in a murky soup of nutrients in huge steel tanks: life forms too small to be seen by the naked eye. These are bacterial strains, which grow and reproduce. Wacker Biotech uses them to produce drugs: so-called Live Microbial Products (LMPs). This is a promising class of therapeutic products. The purpose of these LMPs is to cure or prevent a wide variety of diseases, including cancer as well as infectious, inflammatory, metabolic and dermatological diseases.

LIBATEC®: Wacker Biotech’s Live Bacterial Technology

More and more companies are developing what are referred to as Live Microbial Products – pharmaceuticals that contain living microorganisms. Wacker Biotech is a pioneer in the field of LMP production, having begun LMP contract manufacturing at its Amsterdam site in 2006. Development and production of LMPs at Wacker Biotech are based on an efficient, comprehensive production platform offered under the brand name LIBATEC® (Live Bacterial Technology).

A Partner for the Pharmaceutical Industry

As a CDMO (contract development and manufacturing organization), the company offers its customers production processes that comply with GMP (good manufacturing practice) standards and are tailored to the needs of the project and development phase at hand. The Amsterdam site has several production lines that are available for the production of LMPs and that have been approved by the FDA (the US Food and Drug Administration) and the EMA (European Medicines Agency).

Viability is Key

One of the many challenges in the LMP production process is that sterile filtration is not an option, since LMPs consist of living microorganisms, which would not survive the process. Specialized analytical tests are needed to ensure an adequate number of living microorganisms in the finished product. Over the years, Wacker Biotech has developed extensive expertise in this field.

LIBATEC® Production Process

The first step in manufacturing LMPs is to grow bacteria in a culture medium in small bioreactors. This is followed by fermentation in larger reactors, during which the actual production of microorganisms takes place. In a multi-stage process, the organisms obtained are subsequently separated from undesirable constituents, purified and concentrated. The final steps involve converting the finished LMP to a stable form, dispensing it, packaging it and preparing it for transport. A fill-and-finish plant, including freeze-drying equipment (lyophilization), is available for this purpose at the Amsterdam site.

Advantages at a Glance

Our proven track record and experience in the LMP field allows us to meet the requirements of any project at every development phase. Our expertise extends to:

  • Over a decade of experience in LMP development and manufacturing
  • Replacing animal component-containing media
  • Fermentation regimes for aerobic and specific anaerobic organisms
  • Optimization of upstream and downstream processes
  • GMP-compliant drug substance manufacturing various fermentation scales up to 1,500 liters
  • Closed, monoseptic production systems
  • Process characterization, process validation, clinical and commercial GMP manufacturing experience with LMPs

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