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Microorganims are living organisms with highly specific mode of action, strongly affected by the environment in which they live, in very different ways.
Biopesticides are Plant Protection Products based on microorganims as bacteria, fungi and yeasts. They show several advantages respect to the conventional chemicals including no residues, no pest resistance, environmental footprint and the use in organic farming.
The staff of BioTecnologie BT gained significant experience, over the years, in performing GLP studies on Biopesticides:
- Physical-chemical characterisation
- Active substance content determination
Measuring the Colony Forming Unit (CFU) or by direct microscopic count and determination of the viability.
- Methods validation
Shelf life studies
Cold Stability Testing (0°C) according to CIPAC MT 39.3
Accelerated Storage Stability according to CIPAC MT 46.3
Shelf Life at Room Temperature
5 Batches analysis
The analyses of at least 5 representative batches of production, or pilote-scale batches, is necessary to determine the content of the pure active substance, microbial contaminants and pathogens.The manufacturing processes have the potential of producing unwanted microorganisms in addition to the desired Microbial Pest Control Agents which include pathogens, their associated toxins and other metabolic by-products of health concern.
Search and quantification of contaminants and phatogens are performed according to OECD No. 65 “Issue paper on microbial contaminant limits for microbial pest”.
- In plants, plant products, foodstuffs, feedingstuffs and environmental samples
The laboratory can develop methods to determine residues coming from Plant Protection Products based on microorganims.
- Analytical method validation for residues determination
The laboratory carries out routinely methods validation in matrices resulting from ecotoxicological studies where the tested formulations are based on microorganisms.
MIC determination by agar diffusion procedure using E-TEST
MIC is defined as the lowest concentration of an antimicrobial that can inhibit the visible growth of a microorganism (fungi and yeast) representing a quantitative estimate of the susceptibility of an organism to a certain antimicrobial agent. E-test consists of a predefined, continuous, and exponential gradient of antibiotic concentrations immobilized along plastic test strips which, placed on the surface of agar plate, can release the agent gradually. After the incubation, and the microorganism's growth, the point at which the drop-shaped inhibition zone intersects the graded test strip is defined as the MIC of the antibiotic. A reference standard is used for the quality check of reagents, media and inoculum.
Quantification of Bacillus thuringiensi δ-endotoxins content by SDS PAGE and densitometric analysis
The aim of test is the quantification of Bacillus thuringiensis δ-endotoxins in technical powders, broths and final concentrates resulting from fermentation processes. The assay makes use of electrophoretic separation of the soluble proteins based on their molecular weights. After separation, the relevant protein is quantified by densitometric analysis carried out through specific equipment BIO-RAD Gel Doc 2000TM and its associated software Quantity One.
Biological Compatibility with other products for the combined use
The aim of this test is to evaluate the effects of different products with a microbial formulated product after one or more contact times by the determination of Colony Forming Units (CFU) of the different contact solutions compared with the CFU of the control.