Microbiotica has established a robust and reproducible in-house process development platform for manufacturing the bacteria that form our live biotherapeutic products (LBPs).
Our development platform builds upon our expertise in culturing anaerobic gut bacteria and has allowed us to develop industrialisable processes to grow bacteria, and then preserve them in a stable freeze-dried state.
Robust, scalable and consistent manufacturing process
Unlike undefined products based upon donor stool, such as FMT preparations, our manufacturing starts from clonal master cells banks for each bacterial strain, manufactured to cGMP, allowing us to develop a robust, scalable and consistent manufacturing process where every batch is the same.
To scale processes for cGMP-compliant clinical trial batches we partner with expert contract manufacturing organisations.
Unlike undefined products based upon donor stool, such as FMT preparations, our manufacturing starts from clonal master cells banks for each bacterial strain, manufactured to cGMP, allowing us to develop a robust, scalable and consistent manufacturing process where every batch is the same.
Cell banks are expanded through anaerobic fermentation, and the resulting bacterial cultures are concentrated and resuspended in stabilising formulations which are freeze-dried. The freeze-dried bacteria are blended and filled into bespoke capsules, which protect the bacteria from the stomach following oral dosing and target the bacteria to exactly the right part of the gut.
Our end-to-end LBP preclinical and clinical manufacturing processes involve the following steps:
Master cell banks
The process starts with fully characterised and clonal cGMP master cell banks for each of the individual strains of bacteria.
Fermentation
Each strain of bacteria is fermented in controlled, scalable bioreactors in an oxygen-free environment using proprietary culture media.
Lyophilisation
Proprietary formulations stabilise the metabolic activity, viability and key characteristics of a wide range of bacteria strains.
Blending, fill, finish
The lyophilised bacteria are combined into enteric capsules which release the consortia in the targeted area of the gut.
Quality Control
An extensive array of assays monitors bacterial physiology and product attributes, including safety, to ensure quality ahead of release.
