Microbiology and Infectious Diseases Resources

Examples of Services by Category

Lead Identification and Development

• Design lead optimization schemes (LOS) and generate chemical analogues
• Synthesize, resynthesize, or acquire compounds/interventional agents or chemical analogues for in vitro and in vivo studies
• Analyze structure activity relationships (SAR)
• Custom synthesize radio labeled compounds for in vitro and in vivo studies
• Optimize lead series to improve specific physiochemical or pharmacological properties
• Synthesize prodrug derivative(s.

Chemistry and Manufacturing

• Develop analytical methods to characterize interventional agents
• Develop and manufacture cGMP-qualified materials for preclinical and Phase I/II clinical use
• Conduct formulation studies
• Support cGMP-compliant stability program

In Vitro and In Vivo Preclinical Safety, Toxicology, and Biokinetics

• Develop analytical methods to characterize interventional agents
• Perform preclinical microbiological, safety, biokinetics and toxicity studies, such as in vitro microbiological assays
• Perform in vitro and In vivo pre-clinical safety, toxicology, and biokinetics studies, including
  • maximum tolerated dose and no observed adverse effect levels (NOAEL)
  • acute and sub chronic toxicity
  • PK, Bioavailability, ADME
  • Genotoxicity, carcinogenicity, reproductive toxicity testing
  • Biotransformation assays conducted in vitro
  • Cytotoxicity, immunotoxicity
  • Behavioral pharmacology Cell permeability

Preclinical Development, Planning, and Evaluation

• Develop preclinical and/or product development plans