Global regulatory bodies require sufficient analytical and biological evidence of comparability between reference product and biosimilar candidates. Labs must characterize multiple batches of proteins to establish the biosimilarity of a therapeutic drug candidate to the original reference product molecule.
Waters integrated solutions provide a comprehensive platform for streamlined and robust analysis of the product attributes of biosimilars and their reference products, including:
Partner with Waters to support therapeutic safety and efficacy and improve patient health by confidently establishing comparability of biosimilar products.
Webinar: Deploying Waters Solutions to Enhance Biosimilar Development
Enable biosimilar analyses in every GxP lab with Waters BioAccord LC-MS System, including high-resolution MS and waters_connect software for compliance-ready data analysis and reporting.
Accelerate biosimilar characterization and monitoring with the Xevo G3 QTof high-performance HRMS benchtop system, delivering accurate qualitative and quantitative results.
Obtain ultimate flexibility with the SYNAPT XS mass spectrometer that offers greater freedom of analytical choice to support scientific creativity and technical success for analysis of biosimilars.
Combine novel cyclic ion mobility separation with state-of-the-art high-performance, time-of-flight mass spectrometry with the SELECT SERIES Cyclic IMS, enabling researchers to reliably identify and monitor biosimilar attributes
The DAWNTM MALS detector assists at every development stage. Couple with EclipseTM to measure binding affinity during discovery. Place downstream of any LC and perform advance analysis of biosimilar protein-conjugate ratio, post-translational modifications, and aggregation.
Peptide MAM: Mirror plots showing the comparison of Inflectra to Remicade for both (left) unstressed samples and (right) samples subjected to two weeks of elevated temperature stress.
Peptide MAM: Selected product quality attributes for Remicade (infliximab) and three biosimilars subjected to thermal stress, T0, T1 (1 week), and T2 (2 weeks). Injections 1–3=Remicade (infliximab), 4–6=Inflectra (infliximab), 7–9=Avsola (infliximab), and 10–12=Renflexis (infliximab).
Mirror plots comparing an innovator infliximab sample (Remicade) to two biosimilar samples, (left) Inflectra and (right) Renflexis. The difference in peak intensity is shown as an overlay on each plot, and the Venn diagrams indicate the number of identified glycoforms unique to each sample and those present in both samples.
Overlaid TIC chromatograms of an infliximab originator (Remicade) and a biosimilar (Renflexis) released N-glycan analysis. Some of the glycans differing between the two samples, either in presence or relative abundance, are indicated in the chromatogram with their structures.
Stacked plots of SEC separations on selected columns for biosimilar mAb sample using 1X Dulbecco’s phosphate buffer saline as a mobile phase are shown.
Download
