Bioanalysis

CRO selection and oversight for Bioanalytical and DMPK services

Identification of academic service centers to conduct specialized assays

  Sample tracking and reconciliation

GXP preclinical and clinical bioanalytical strategy development and assessment including method development, method validation, method transfer and sample analysis for small molecules, peptides and vaccines

• First in Human 
• Translational Medicine 
• Pivotal and Late Development Assays 
• Toxicology 

Quantitative immunoassays and LC/MS methods can provide rapid, sensitive data driving candidate selection.  Developing a method with the correct level of rigor requires deep technical expertise and a focused sense of urgency.

Discovering and developing drug candidates requires not only measurement of the molecule itself but bioanalytical methods that monitor a pharmacodynamic response known as a biomarker.  In addition, LC/MS can monitor engagement to the target protein of interest.