Embracing LC-MS Analytical Techniques Into Regulated Laboratories

By Heather Longden

Biopharmaceutical regulations and regulatory guidance help to ensure high performance across the industry, enabling laboratories to create better and more consistent drug therapies. Though the rules around compliance can be complex, they provide the structure for the pharmaceutical industry to succeed in releasing a safe and effective product.

To ensure compliance success in a changing regulatory landscape, laboratories must continually adapt in order to maintain compliance. Biopharma is presented with an additional compliance challenge, as the field requires complex analytical instruments that are not traditionally used in highly regulated labs.

One solution is the utilization of compliant-ready liquid chromatography-mass spectrometry (LC-MS), which can provide mass spectrometry detection for quality control analysis in Biopharma. As a fit-for-purpose, compliant-ready LC-MS system, Waters’ new BioAccord LC-MS platform addresses the biopharma compliance challenge by helping laboratories replace their less sensitive optical-based assays with a more advanced methodology.