ADC PK Profiling Strategies on LC-MS Platforms: Top-down, Bottom-up…
With more monoclonal antibody (mAb) drug conjugates (ADC’s) under preclinical development and in clinical studies, comprehensive and reliable pharmacokinetic evaluation of ADC moieties is increasingly demanded. Liquid chromatography coupled to mass spectrometry (LC-MS) methods have served as sensitive, selective, and versatile tools for ADC PK profiling. Presented here are ADC LC-MS methodology approaches used at Frontage.
Frontage Laboratories Company Overview
Frontage Laboratories, Inc. is a CRO providing integrated, scientifically-driven research, analytical and development services. With over 17 years of experience, we have successfully assisted our clients in advancing hundreds of compounds through the drug development process.
Requirements for a Derma-Patch Study
This study evaluated the safety of a pain medication that was administered through a topical dermal patch and the effect of the compounds on the adhesive properties at different environmental temperatures. Recruiting this study was challenging. It required recruiting subjects in two different seasons.
CMC GMP Analytical Testing
Biologics or biopharmaceuticals are inherently more complex than small-molecule drugs. You need the right team to help you. Frontage has expertise and state of the art instrumentation necessary for the analytical method development, validation and transfer for complex biopharmaceutical compounds. Using bottom up, middle up/down, and top down approaches, we offer analytical support for characterization of primary, secondary and tertiary structures, post translational modifications such as glycosylation, disulfide linkage, antibody drug conjugation, or PEGylation.
FCS Business Continuity Plan
In accordance with the Centers for Disease Control and Prevention (CDC) recommendations, Frontage
Clinical Services (FCS) will re-open clinic conduct activity with extensive policies and procedures in place
to protect FCS staff and subjects engaged in clinical conduct activities that require face-to-face
interaction in clinic settings