White Papers
Development and Validation of a Fluorometric Assay for Quantification of D-Lactate as a Marker of PLA/PLGA Degradation
Overview
Medical device developers and drug delivery scientists face increasing regulatory scrutiny around polymer-based implants, especially those using PLA and PLGA. Accurately monitoring degradation products is essential for proving product safety, performance, and longevity.
In this new white paper, BioAssay Systems details the development and validation of a fluorometric D-lactate assay to directly quantify PLA/PLGA degradation in complex biological matrices—including stents and tissue samples.
What's Inside:
- Enzymatic specificity for D-lactate – Detect polymer-derived degradation without interference from endogenous L-lactate
- Compatible with stent -tissue explants – No tissue separation required, minimizing sample handling
- High sensitivity & reproducibility – Quantifies as little as 50 ng polymer with linear detection over a broad range
- Proven in regulatory filings – Assay supported multiple CE Mark approvals and IDE applications