Product

Biopesticides

Biopesticides products are based on microorganisms (bacteria, fungi and viruses), plant extracts, peptides, secondary metabolites, semiochemicals derived from natural sources. These products can be used alone or in strategy supporting conventional PPPs against different plant pests and diseases.

They can provide a real alternative to synthetic chemicals also supporting them in the efficacy action to control pest populations ensuring high quality yield production of different crop.

Services

For product development

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Product engineering

Isolation and identification of microorganisms and/or extraction of metabolites and peptides

Discovery: In vitro / in vivo (e.g. MIC and synergism evaluation with  the identification the LD90 against the pathogens).

Formulation development considering the intrinsic properties of the main actives

Pilot production: upstream (e.g. fermentation and plant extraction) and downstream (e.g. concentration of the fermentation broth and purification process)

Industrial scale-up: upstream, downstream and formulation steps

Services

For registration (consultancy services)

According to the 1107/2009 and the data requirements EU no. 283/2013 and 284/2013

Data Gap Analysis (eventual preliminary Risk Assessment) and Regulatory Strategy

Dossier preparation (MA + MP) following the specific guidance

  • SANCO/12545/2014 rev 2 (Microbial Agents)
  • SANCO/12815/2014 rev 5.2 (Semiochemicals)
  • SANCO/11470/2012 rev 8 (Botanicals - plant extract)

Biological Assessment Dossier (BAD) preparation

Risk Assessment for humans and environmental

National applications in the EU countries

Scientific support and study monitoring

Meetings with Authorities and Contract Institutes

Registration

Additionally, KISAR BIOSOLUTIONS can contract, design and/or monitor studies for dossier preparation. Adaptations on study design can be provided by our expert group and study directors in the different dossier sections.

Depending on the study type it is possible to decide whether GLP, GEP or usual laboratory conditions are required.

Services

For EU registration (supporting activities)

Microbial analysis (whole genome sequence analysis (WGS), metabolites and toxins screening, minimum inhibitory concentration (MIC) determination for antibiotics and other anti-microbial agents, 5-batch analysis under GLP conditions)

Physico-chemical properties of the preparation (storage stability, shelf-life, technical characteristics, compatibility aspects)

Efficacy data package according to the GAP table under GEP conditions (including preliminary tests, efficacy trials, resistance information, effects on quality and quantity, phytotoxicity, adverse effects, observations on undesirable or unintended crops)

Effects on Human Health – basic studies under GLP conditions (acute toxicity, pathogenicity and infectiveness), if relevant genotoxicity, cell culture and short-term toxicity studies

Residues on treated products – statements and spore decline curve

Environmental fate – initial PEDs calculations, microbial persistent studies

Non target organism studies on aquatics and terrestrials organisms

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