Analytical/Bioanalytical Method Development and Validation
Pacific BioLabs has vast experience in analytical and bioanalytical method development and validation for a variety of platforms including HPLC, LC/MS/MS, GC/MS or GC/FID, ICP/MS, and ligand binding assays (MSD, ELISA or other cell-based assays). As both an in vivo and analytical chemistry CRO, we support product development of a variety of pharmaceuticals, biologics and medical devices at all stages of the product life cycle. Method development and validation is an important first step to determine that analytes of interest can be reliably detected and quantified for routine sample analysis. Our team includes three lead scientists that each have over 20 years experience in method development. They will work with you to understand your needs and develop a plan for your product’s analytical development. Based on our extensive experience with similar products and by drawing upon published literature resources, PBL can swiftly develop the most appropriate method for your product.
After method development, PBL can validate the method according to FDA, USP, EP or ICH guidelines to determine its suitability for its intended use. PBL is flexible in supporting complete or partial validations, re-validations and method transfers. PBL provides full documentation including a fully QC/QA reviewed protocol, method SOP, and report for the analyses. In addition, many methods for marketed drug products have been validated by PBL and are available to our clients.
The Analytical Team at PBL has developed methods for very challenging analytes including urine, brain and plasma biomarkers for glycosaminoglycan (GAG) metabolism, strontium heavy metal quantification in pig skin, and numerous drugs in simulated gastrointestinal fluids. The below links provide a list of validated methods as well as case studies of several method validation projects that highlight the experience and capabilities of PBL’s analytical department.
Read More About Method Development and Validation
- PBL Case Study: Challenges in Method Development for Drug Interaction Studies
- PBL Case Study: PBL Contributes to Successful Phase 3 Trial of BioMarin Orphan Drug
- PBL Case Study: Quantitative bioanalysis of strontium in human serum by inductively coupled plasma-mass spectrometry
- PBL’s Learning Center – CMC Activities for Biologics and Monoclonal Antibodies
- PBL’s Learning Center – Pharmaceutical CMC Expectations