To provide stable bacterial extract preparations with substantially increased stability with time, methods for preparation thereof, pharmaceutical formulations based on these stable bacterial extracts, and administration routes and delivery devices to treat and / or preventing immunological disorders due to infection and / or
inflammation and / or neoplasms and / or
dysbiosis.SOLUTION: Provided is a pharmaceutical composition comprising a bacterial extract from one or more
Gram-positive or
Gram-negative bacterial species and a pharmaceutically acceptable
excipient or vehicle, where the bacterial extract is prepared as follows: subjecting one or more
Gram-positive or Gram-negative bacterial species to
alkaline lysis at a pH higher than 10; adjusting the pH of the lysate to 5-8 with one or more organic acids; conducting
filtration using a filter of 1.2 micron to 0.1 micron followed by
filtration using a filter of a
cut-off value of 10 kDa to 100 kDa for purification, and finally adjusting the final physiological pH to from 5 to 8.SELECTED DRAWING: Figure 18