Support Services

Our on–site support services provide you with the full range of analytical and radiochemical expertise that you need for swift and efficient drug development. Analytical studies are designed to fully comply with GLP and GMP regulatory standards. Our radiochemical and stable label synthesis services for metabolism and toxicology studies are customized to give you the best possible approach to meeting project requirements. From preclinical to post–marketing phases, your team will be fully supported at Ricerca.

Analytical Services

Ricerca offers a comprehensive range of analytical chemistry services on site. These range from GLP dose formulation analysis on safety studies to cGMP batch release testing. With decades of direct experience in conducting studies designed to comply with regulatory standards, we fully support you in the drug development process, from preclinical to post–marketing.

Our preclinical and early–phase services include material characterization, pre–formulation, and dose formulation analysis. Support through middle– and late–phase testing includes method development and validation, stability and QC testing, and process development and API manufacturing and support.

Ricerca’s specialized analytical abilities include:
  • Dose analysis for nonclinical studies
  • Radiochemical analyses
  • Impurity isolation and synthesis
  • Impurity identification and structure elucidation
  • Extractable and leachable assessment programs

Large Molecule Bioanalytical Services

Ricerca’s skilled scientists and technicians have the experience and in–depth knowledge required to rapidly and accurately quantify bioanalytical samples using Ligand–Binding Assays for large molecules.

Ricerca’s bioanalytical services include:
  • ELISA for biomolecules
  • Flow cytometry for response or biomarker identification
  • Sample analysis for nonclinical studies
  • Discovery PK study support
  • WinNonlin Software for kinetic and exposure modeling

Radiochemical and Stable Label Synthesis

For over 25 years, Ricerca has provided custom radiochemical and stable label synthesis services for small molecules. In support of drug safety studies, radiolabeled candidates are employed in ADME studies, whereas stable labeled drugs are used as internal standards for bioanalytical quantitation in DMPK and toxicology studies. Ricerca is one of the very few firms that can offer radiosynthesis and drug safety studies at a single site. We guarantee a smooth transition and the shortest possible timing between synthesis and use in animal studies. This on–site arrangement is optimal for use with unstable radiolabeled test articles.

We are experienced at developing novel synthetic routes to meet specific labeling requirements. Our skilled and proficient scientists give your development team the best possible support to meet project requirements. Ricerca’s laboratory includes dedicated preparative HPLC instrumentation as well as dedicated analytical HPLCs, on–site LC–MS capability, and a gas transfer manifold for isotopic labeling using volatile radiochemicals.
  • Radiolabeled (14C,3H, 32P, 35S, 131I, 125I, 99Te, 36Cl) compound production
  • Stable–labeled (13C, 2H,15N) compound production
  • 14C labeled polymer synthesis
  • High–purity radiochemicals preparation
  • Chiral isomer separation
  • Reference standards
  • cGMP preparation and release of labeled APIs
  • Non–GMP preparation and GLP characterization
  • Storage and distribution of labeled compounds
  • Dilution of labeled compounds (including non–GMP and cGMP blending)
  • Stability studies