Biologics have transformed healthcare with their remarkable therapeutic potential and specificity. To develop and market these biopharmaceuticals effectively, a deep understanding of product variability, degradation pathways, and production processes is essential, all of which made possible by methods such as mass spectrometry under GMP. Analytical labs face the challenge of optimizing instrument utilization to meet the demand for precise qualitative and quantitative data. This necessitates versatile multifunctional equipment that can adapt to diverse applications, such as GMP-ready Liquid Chromatography-Mass Spectrometry/(LC-MS) for comprehensive testing of biologics, enabling detailed characterization and quantitative analysis to ensure product quality and safety. 

The Xevo G3 QTof system is precisely that - a versatile and advanced tool for mass spectrometry under GMP, characterizing and measuring molecules in various fields, including biotherapeutics, forensics, metabolite identification, metabolomics, and extractables and leachable analysis. Maintaining GMP compliance with such powerful tool is a challenge in itself, however, the Xevo G3 QTof system paired with its Waters connect software allows for data integrity levels that meet the requirements of the 21 CFR part 11.

At Biodextris, we provide an extensive array of thorough analyses for detecting and quantifying a broad spectrum of substances, from small molecules to intricate biotherapeutic compounds, in R&D or clinical contexts. GMP mass spectrometry using the Xevo G3 QTof thus complements our QC expertise, allowing for the analysis of post-translation modification and high-throughput intact mass screening, while ensuring data integrity.

Post-Translational Modification Analysis 

Multi-attribute method (MAM) assays using GMP-ready LC-MS are becoming more popular in the biopharmaceutical industry due to their ability to directly measure various characteristics, such as product variability and degradation. Through the utilization of improved ion optics and beam conditioning, our mass spectrometry system under GMP enhances peptide transmission, allowing for comprehensive quantification. This increased precision streamlines the process for extensive peptide mapping and dependable quantification of attributes like deamidation, oxidation, lysine clipping, and glycosylation. Furthermore, by leveraging established peptide MAM, we efficiently monitor critical quality attributes (CQAs) across a variety of sample sets analyzed through GMP compliant mass spectrometry.

High-Throughput Intact Mass Screening

With Data-Independent Acquisition (DIA) modes and advanced Waters Connect applications, the GMP-ready Xevo G3mass spectrometry system streamlines workflow to deliver comprehensive reports encompassing basic mass verification, high-throughput intact mass screening, and impurity profiling—all from a single injection.

Data integrity with GMP-compliant software and automated calibration

Backed by our expertise, we navigate the complexities of biopharmaceutical analysis with finesse. Our commitment to achieving the highest levels of quality and data integrity is unwavering, upheld by GMP-compliant software and automated routine calibration. Every aspect, from instrument validation to creating reports, is meticulously conducted to fulfill regulatory requirements and adhere to industry standards for conducting comprehensive GMP mass spectrometry, paving the way for setting new analytical benchmarks in biologics development across all phases.