Interlaboratory evaluation of a user-friendly benchtop mass spectrometer for Multi-Attribute Monitoring studies
(1) Quality Assistance sa, Technoparc de Thudinie 2, 6536 Thuin, Belgium
(2) School of Pharmaceutical Sciences, University of Geneva, CMU—Rue Michel Servet 1, 1211 Geneva, Switzerland
(3) Institute of Pharmaceutical Sciences of Western Switzerland, University of Geneva, CMU—Rue Michel Servet 1, 1211 Geneva, Switzerland
(4) Laboratoire de Spectrométrie de Masse BioOrganique, Université de Strasbourg, CNRS, IPHC UMR 7178, 67000 Strasbourg, France
(5) Infrastructure Nationale de Protéomique ProFI—FR2048, 67087 Strasbourg, France
(6) Biologics CMC and Developability, IRPF, Centre d’Immunologie Pierre Fabre, 5 Avenue Napoleon III, 74160 Saint-Julien en Genevois, France
* Correspondence: gery.vanvyncht@quality-assistance.be
† These authors contributed equally to this work.
Multi-Attribute Monitoring (MAM) heralds a new era in quality control, transcending the conventional single attribute monitoring method by assessing multiple product characteristics simultaneously. Emerging in 2015, MAM integrates advanced analytical techniques for a more comprehensive evaluation of products. While MAM offers transformative potential for quality control, its application faces challenges. Technically, it demands sophisticated analytical tools and specialised expertise. Regulatory standards for MAM are complex and continually evolving. Logistically, MAM requires substantial investments in advanced equipment and trained personnel. Despite these challenges, MAM holds immense promise for enhancing quality control processes, driving ongoing research and innovation to overcome the existing hurdles.
In this interlaboratory study, we show that Waters BioAccord system, a user-friendly benchtop mass spectrometer, can be used together with waters_connect software to implement MAM methodology in QC laboratories.
Download the poster below 🔽
This subject has also be presented by Arnaud Delobel during a webinar
