Does Your Electronic Data System Meet 21 CFR Part 11 and CGMP Requirements?

Monoclonal antibodies (mAbs) are effective therapeutics for cancers, auto-immune diseases, viral infections, and other diseases. Recent developments in antibody therapeutics aim to add more specific binding regions (bi- and multi-specificity) to increase their effectiveness and/or to downsize the molecule to the specific binding regions (for example, scFv or Fab fragment) to achieve better penetration of the tissue. As the molecule gets more complex, the possible high and low molecular weight (H/LMW) impurities become more complex, too. In order to accurately analyze the various species, more advanced detection than ultraviolet (UV) is required to characterize a mAb sample.

Wyatt’s instruments and techniques constitute platform methods for effective product and process development, as well as quality control, of AAVs for gene therapy.

Efficient and accurate HPLC analysis of lamotrigine in compliance with USP

USP-compliant assay analysis of hydrocortisone using a PerkinElmer LC 300 HPLC System

Efficient and compliant HPLC analysis of pregabalin

A rapid and simple LC method for the analysis of six common VOC metabolites in urine for monitoring occupational exposure to VOCs