Services for Researchers

Services for the Preclinical Development of Therapeutic Agents

Examples of Services by Category

Lead identification and development

• Chemical Screening
• Lead optimization schemes
• Synthesis or resynthesis of chemical analogues
• Custom synthesis of radiolabeled compounds
• Limited optimization of chemical lead series
• Use in silico systems to predict ADME and toxic properties

Chemistry and Manufacturing

• Therapeutic agent characterization
• Stability studies
• Synthesis/resynthesis/purchase of compounds and therapeutic agents
• Current Good Manufacturing Practices (cGMP)
• Formulation

In vitro microbiological services

• Minimum inhibitory concentration (MIC), Minimum bactericidal concentration (MBC)
• Dose response studies
• Mechanism of action
• Drug resistance analysis

In vitro and in vivo preclinical safety, toxicology and biokinetics

• Maximum tolerated dose (MTD) and no observed effect level (NOEL)
• Cell (e.g. IC50), immunotoxicity, behavioral pharmacology, cell permeability
• Carcinogenicity
• In vitro biotransformation assays
• Cytotoxicity of compounds for actively dividing mammalian cells
• Investigational New Drug (IND)/New Drug Application (NDA)/Biologics License Applications (BLA) enabling studies
• Toxicity studies
• Pharmacokinetic/toxicokinetic (PK/TK)
• Bioavailability
• Absorption, Distribution, Metabolism, and Excretion/Elimination (ADME)
• Reproductive toxicology studies
• Genetic toxicology studies

Preclinical development planning and evaluation service

• Develop an overall preclinical development plan for specified candidates
• Review and evaluate preclinical therapeutic development activities and plans in terms of adequacy of potential regulatory submission