Bioanalytical

Bioanalytical (Bio-A) laboratory services are the cornerstone to the success of preclinical PK and toxicology studies, providing drug concentration analysis of dose samples, serum, fluids, and tissues. Our bioanalytical services include LCMS/HPLC/ELISA method development, method transfer, method qualification, method validation, and sample analysis in complex biological fluids (plasma, serum, whole blood, CSF, etc.) and tissues. We cover all stages of drug development that span discovery, pre-clinical, and clinical studies and we work with all types of drug candidates ranging from small molecules to mAbs/ADCs. Our highly experienced and trained staff can solve even your toughest problems and get you to the finish line with constant communication to remove the guess work.

Our GLP-compliant bioanalytical laboratory is onsite at our single Chicago, IL location for efficient and transport-free coordination of study teams and sample analysis. We comply with FDA guidelines for bioanalytical method validation and quantitation of your small molecule or biologic from preclinical studies like bioavailability /bioequivalence, and biodistribution to GLP-compliant IND enabling programs. We also support clinical sample analysis for Phase I, II, and III trials. Additionally, our bioanalytical team is capable of performing PK analysis to provide important PK parameters such as t_1/2, T_max, C_max, AUCs, etc. thereby offering you a complete package of bioanalytical services under one roof.

The IITRI Advantage

• Highly experienced bioanalytical team with greater than 60% of the scientists holding advanced degrees
• Expertise in GLP ELISA method development and validation and molecular biology techniques
• Smooth transfer of methods and data to/from central lab of choice