A Full Range of Services for Agrochemical Development

Ricerca Biosciences is a contract research organization with exceptional capabilities to provide testing for compounds developed for agriculture and veterinary care. We offer entire packages of services from our beautiful 43-acre campus in Concord, Ohio, (less than one hour east of Cleveland). Three major buildings with 260,000 square feet of space house Ricerca's 125 well-equipped and modern laboratories. In addition, we also have newly-constructed greenhouses and an outdoor plot for radio isotope field studies.

With over 25 years of experience in registering agrochemicals, Ricerca provides a knowledgeable and competent staff to assist with your product development. From efficacy determination to final regulatory approval, Ricerca can help with all aspects of EPA-FIFRA, FDA-CVM, OECD, JMAFF, PMRA or other global regulatory acceptance. Following is a brief overview of Ricerca's agrochemical services.

 

Regulatory Studies

A full suite of regulatory studies can be performed by Ricerca's in-house scientists and technicians to support submissions to the EPA and other regulatory bodies. The following is a complete listing:

 

Environmental Fate/Residue Chemistry

  • Degradation (hydrolysis, photodegradation)
  • Aerobic and anaerobic metabolism (soil, aquatic)
  • Mobility (absorption/desorption, soil column leaching, lab volatility)
  • Prospective/retrospective groundwater
  • Fish bioaccumulation (metabolite identification)
  • Confined accumulation (rotational crop)
  • Field rotational crop

 

Nature of the Residue

  • Plant Metabolism
    • Metabolite identification
    • Distribution studies
    • Reincorporation methodology (14 C)
  • Animal Metabolism
    • Absorption, distribution, excretion
    • Single and multiple dose
    • Oral, dermal, IP, IV
    • Special surgical techniques (bile duct cannulation; jugular cannulation)
    • Metabolite identification and quantitation

 

Magnitude of the Residue

  • Crop field trials and storage stability
  • Livestock feeding studies (cattle, poultry)
  • Market basket surveys
  • Independent Laboratory Validations (ILV)

 

Toxicology

  • Subchronic
    • 21- and 90-day dermal
    • 90-day gavage
    • 90-day dietary

 

Chronic Toxicity/Oncogenicity

 

Neurotoxicity

  • Developmental
  • Functional observation battery
  • Motor activity assessment

 

Target Animal Safety

 

Product Chemistry

  • Product chemistry packages (active ingredient, formulation)
  • Methods development and validation
  • GLP characterization test, control, reference substances
  • Certificate of Analysis (FIFRA, TSCA, OECD, J-MAFF Requirements)

 

Analytical Chemistry

Ricerca's modern laboratories offer a comprehensive range of services in analytical chemistry, including GLP characterization of test and reference materials, method development and independent laboratory validation. Our complete product chemistry is carried out in conformance with regulatory guidelines established by EEC, JMAFF and USEPA OPPTS.

 

Analytical Chemistry Services Include:

  • GLP characterization of test and reference materials
  • Analytical method development
  • Independent Laboratory Validation
  • Comprehensive product chemistry in conformance with regulatory guidelines as established by EEC, JMAFF and USEPA OPPTS
  • 5-batch analysis
  • Impurity determinations
  • Vapor pressure
  • Stability studies

 

 

Process Chemistry

Preparation of agricultural chemicals requires in-depth knowledge of complex, multi-step organic synthesis, as well as expertise in chemical engineering in order to create efficient, safe and cost-effective processes. Ricerca's process chemistry services include process research and development designed to minimize projected commercial-scale manufacturing costs.

/ / / Ricerca's Process Chemistry Services Include:

  • Chemical route scouting and selection
  • Process research
  • Process development (conducted in conjunction with economic modeling in order to minimize projected commercial-scale manufacturing cost)
  • Process optimization
  • Process robustness testing
  • Technology transfer

 

Custom Manufacturing

At Ricerca we conduct custom manufacturing in kilo labs and in our own pilot plant to produce materials for our agrochemical clients. Ricerca has demonstrated expertise in complex, multi-step synthesis including:

  • Small-volume preparation of active materials in kilo-lab quantities
  • Large-scale preparation of intermediates in pilot plant
  • Preparation of radio-labeled compounds
  • Synthesis of metabolites
  • Synthesis of standards

 

Problem Solving

  • Deformulations
  • Trace impurity isolation/identification

 

Technical Support of Registration Packages

  • Program Management and Consulting
    • Project coordination
    • Technical-regulatory agency interface
    • Scientific soundness review of registration packages (U.S., Canadian, European, J-MAFF)
  • Study Package Assembly
    • Dossier preparation (EU, Canada)
    • Post-FQPA registration issues (U.S.)
    • Modeling and risk assessments

 

Synthetic Chemistry

  • Analytical standards, model compounds, metabolites
  • Radiolabel synthesis

 

Process Services

  • Material Preps
    • (Grams to kgs to metric tons)
    • Product candidates
    • Intermediates
    • Process discovery, development and optimization
    • Contract manufacturing under GMP/GLP