Today's world faces the growing resistance of bacterial agents to many diseases to conventional treatments. Due to the excessive use of antibiotics in human and veterinary medicine, the number of bacteria resistant to known antibiotics is growing. Our project is focused on innovative immunological preparations based on bacterial and phage lysates. These products have a demonstrable immunomodulatory effect and their immunomodulatory effect is also used by a number of mass-produced medicinal products. In addition to the immunomodulatory effect, the therapeutic effect of phage lysates also uses the activities of the lysate itself (the bactericidal effect of the phage component present). Thus, phage-based immunobiological drugs have significant potential in the search for an alternative to the growing resistance of bacteria to antibiotic therapy. If these immunobiological products are to have the character of active substances usable for the manufacture of medicinal products, they must meet, in addition to the safety criteria, the requirements for the definition of efficacy. However, reliable, demonstrable and commercially viable efficacy tests for the above-mentioned substances are generally lacking in the EU. The output of our project will be bacteria methods enabling the identification and quantification of specific and non-specific immune responses elicited by bacterial or phage lysates and their combinations. The methods developed within the project will then allow us (and other manufacturers) to precisely define the effectiveness of the products produced and then further improve these products. The methods will also be used in the preparation of new products, as well as in monitoring the effectiveness of existing ones. The project will also include the use of developed methods in monitoring biological efficacy over time, specifically for phage lysates.