Having our own production facility empowers Servatus to meticulously manage every stage of the research, development and production pipeline processes. This enables us to ensure that our live biotherapeutic drug candidates (LBPs) meet our rigorous standards and specifications. Additionally, it eliminates the logistical uncertainties often associated with outsourcing manufacturing.
Servatus has completed construction of Stage 1 of our State-of-the-Art R&D and cGMP-compliant manufacturing facility.
Equipped with in-house capabilities, we can undertake processes such as fermenting, concentrating, and drying of our bacterial strains. All of this is achieved through our proprietary production methodologies, supported by custom-designed automation skids, which seamlessly orchestrate our continuous manufacturing process.
Stage 2 of the facility is currently in the planning phase and will enable us to expand our manufacturing capacity and staff resources as the company grows, eliminating the need for continuous relocation.
Manufacturing stands as a pivotal stage in LBP development that is often overlooked. While research and initial development typically garner attention, the physical and logistical facets of mass-producing pharmaceuticals receive insufficient focus. This oversight yields technological hurdles and unnecessary delays when scaling up becomes necessary. Servatus addresses this challenge by securing its own private manufacturing facility, enabling testing and scale-up production in-house. Leveraging our proven automated and continuous manufacturing process alongside proprietary bioprocessing methods, we ensure efficient production.
By controlling production at our facility and utilising our specially designed bioprocesses, we not only innovate novel LBP drug variants, but we also develop proprietary media and production systems, including very low temperature spray drying for continuous production of high quality live microbial biotherapeutics.
Our bio-manufacturing process employs a proprietary closed system, with continuous production controlled by process automation skids. Further, electrostatic spray drying (ESD) at low temperatures (as low as 30oC) enhances both recovery rates and production cost-effectiveness.
Moreover, our proprietary media has been meticulously developed to support high viable cell density (>1.0E10 cells/ml), and to surpass stringent global regulatory standards for compliance.