Inoculation & Precultures
The strains are provided by the customer.
LBPs: 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 Biotherapeutic Products (LBPs). This is a promising class of therapeutic products. The purpose of these LBPs 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 Biotherapeutic Products – pharmaceuticals that contain living microorganisms. Wacker Biotech is a pioneer in the field of LBP production, having begun LBP contract manufacturing at its Amsterdam site in 2006. Development and production of LBPs at Wacker Biotech are based on an efficient, comprehensive production platform offered under the brand name LIBATEC® (Li ve Ba cterial Tec hnology).
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 LBPs 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 LBP production process is that sterile filtration is not an option, since LBPs 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
Fermentation
Leveraging Wacker Biotech’s EMA/FDA-approved manufacturing lines (ranging from 250 L single-use to 1500 L stainless-steel fermenters) allows customers to adjust the scale of GMP processes to meet the needs of each project and development phase.
Yield & TFF
An existing centrifugation step is usually replaced with an ultra-/ micro-filtration step using tangential flow filtration (TFF). This is also a disposable technology and ensures the process remains closed and monoseptic at all stages.
Drug Substance
Bulk drug substances can be dispensed into trays and lyophilized. Bulk lyophilization runs up to 65 L are supported.
Drug Product
Aseptic filling operations are carried out within Wacker Biotech’s GMP fill & finish facility, which includes both a formulation/ preparation area and a principal filling area.
Liquid Formulation or Lyophilization
Drug products can be dispensed into vials. Batch fills are possible up to 20,000 units (DIN 2R to 20R) for both liquid and lyophilized formulations.
The first step in manufacturing LBPs 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 LBP 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 LBP field allows us to meet the requirements of any project at every development phase. Our expertise extends to:
- Over a decade of experience in LBP 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 LBPs
All Information on Biopharmaceuticals
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