Development of new methods for monitoring the biological activity of bacterial & phage lysates (BIO)

IDENTIFICATION CODE: CZ.01.1.02/0.0/0.0/16_084/0009987

PROJECT DRAWING DATE: 2017–2020

The current world is facing a problem with the increasing resistance of bacterial agents to many diseases compared to conventional treatments. Due to the excessive use of antibiotics in human and veterinary medicine, the number of bacteria resistant to known antibiotics is increasing. 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 many mass-produced medicinal products. The therapeutical effect of phage lysates additionally uses, in addition to immunomodulatory, the activities of the lysate itself (the bactericidal effect of the phage component present). Immunobiological phage-based pharmaceuticals have so much potential to find an alternative to the increasing resistance of bacteria to antibiotic therapy. If these immunobiological preparations are to have the nature of medicinal substances that are useful in 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 trials are lacking in the EU for the substances mentioned above. The output of our project will be a battery of methods enabling the identification and quantification of specific and non-specific immune responses induced by bacterial or phage lysates and their combinations. The methods developed within the project will allow us (and other manufacturers) to accurately define the efficacy of the manufactured products and then further improve these products. The methods will also be used to prepare new formulations as well as to monitor the efficacy of the present ones. Part of the project will also be the use of developed methods for monitoring bioavailability in time specifically for phage lysates.

Biotechnologically modified collagenase for the preparation of advanced therapy medicinal products

IDENTIFICATION CODE: FV20139

PROJECT DRAWING DATE: 2017-2021

The aim of the project is to develop advanced production technologies of highly effective purification of individual proteases, which are an active part of traditional collagenase preparations. They are prepared by fermentation of strains of Clostridium histolyticum. Besides collagenases of classes 1 and 2 they also contain undesirable components, including endotoxin. Separation by filtration and high-performance liquid chromatography will result in pure monocomponent fractions.Modified collagenase will be further produced with an affinity tag to facilitate its separation. Separated proteases will be combined according to the desired determination. The resulting formulations will serve to efficiently disintegrate organs and tissues for the preparation of defined cell populations and tissue structures. These are necessary for the preparation of so-called "modern therapy" products, whose production process legislatively requires a declaration of high purity and a defined activity of all the means used.

Development of new drugs for fish, bees and bovine mammary gland diseases based on bacteriophages. Co-financed by the European Union.

IDENTIFICATION CODE: CZ.01.1.02 / 0.0 / 0.0 / 15_019 / 0004353

PROJECT DRAWING DATE: 2015-2019

The project focuses on the development of new veterinary products for the treatment of bacterial diseases of fish, bees and inflammation of the mammary gland in cattle using specific bacteriophages for the particular cause of the disease. The result of the project will be the development of a suitable and effective method of preparing specific phages of replication on particular bacteria, their identification and quantification and processing by purification processes and the development of a suitable pharmaceutical form of the drug so that they can be used as pharmaceuticals. The aim of the project is to build a pilot plant to produce new medicines.

Project for the protection of industrial property - MB PHARMA Ltd. It is co-financed by the European Union.

IDENTIFICATION CODE: CZ.01.1.02 / 0.0 / 0.0 / 15_030 / 0005988

PROJECT DEATHLINE: 2016-2020

The aim of the project is to protect the industrial property rights of MB PHARMA s.r.o. MB PHARMA puts great emphasis on protecting intellectual property (IP). IP of new products will be protected by a portfolio of international and EU trademarks that will build on the existing portfolio of domestic trademarks. These protected designations will be a symbol of the guarantee and quality of the new products that the applicant offers and sells on the domestic and foreign markets. We are also preparing the patent protection of the process of preparation and control of the development result within the so-called biotechnological patent and utility model.

Collagenase for the isolation of Langerhans islets

IDENTIFICATION CODE: TA04010038

PROJECT DEATHLINE: 2014–2017

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The aim of the project is to develop a preparation based on the collagenase enzyme with a high tryptic activity and standard properties, primarily intended for cleavage of pancreatic collagen in isolation of Langerhans islets. The absence of a preparation with a standard activity is one of the main factors currently preventing a better use of available pancreases from brain-dead organ donors and a wider use of Langerhans islets transplantation in treating diabetes type 1. There is also a partial aim: to determine through experiments a suitable composition of the preparation (representation of various isoenzymes and additional proteases), to develop a procedure for its reproducible preparation, to work out a way of using it in isolation of Langerhans islets in animals a finally in pre-clinical studies prove its safety from the morphological point of view and function of insulin-producing beta cells. Efficacy and safety of the preparation will also be tested in a pre-clinical model of treatment of experimental diabetes by transplantation of isolated islets under renal capsule and through vena portae in the liver. Other tests will concern the suitability of the preparation in dissociation of other types of tissue, where a commercial application can also be expected. The preparation developed in the final phase of the project will be offered for testing to leading world laboratories which isolate Langerhans islets and which have already expressed interest in the new product.