Q&A: Biosimilar Characterization: Leveraging Protein Analytical Technology within GMP Guidelines to Design a Pathway to a Successful Product

10 Dec 2013

Q&A from the successful Waters Corporation and Covance webinar 'Biosimilar Characterization: Leveraging Protein Analytical Technology within GMP Guidelines to Design a Pathway to a Successful Product', hosted by SelectScience in October 2013. GMP standards, de-salting, scarce proteins, Lysine digestion and the use of Mass Lnyx and UNIFI software are all discussed.

ACQUITY UPLC H-Class PLUS Bio System

Waters

The ACQUITY UPLC H-Class PLUS Bio System delivers the benefits of UPLC's resolution, sensitivity, and throughput in a system purpose-built for the analysis of proteins, peptides, nucleic acids, and glycans.

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MassLynx MS Software

Waters

Acquire, Analyze, Manage, and Share Mass Spectrometry Information MassLynx™ Software increases the speed at which you can convert your sample data into valuable knowledge. It provides you with the fundamental platform to acquire, analyze, manage, and share your mass spectrometry information. MassLynx intelligently controls any Waters mass spectrometry system, from sample and solvent management components to mass spectrometer and auxiliary detectors. MassLynx Software may acquire nominal mass, exact mass, MS/MS and exact mass MS/MS data. MassLynx’s Sample List is the core of the system. It maintains and consolidates the data on all of your samples. You also initiate any activities related to your sample from the Sample List. This "sample centric" approach simplifies the interaction with your LC/MS or GC/MS system, acquired data and processed results. Process Application-specific Data MassLynx Software features general purpose and specialized Application Managers that provide information for your specific MS analyses and data. Two come standard with MassLynx: QuanLynx™ for automated quantification included as standard with MassLynx OpenLynx™ for qualitative screening and identification Optional Application Managers can perform: Targeted quantitative analysis Mass-directed purification Metabolite identification Deconvolution of complex chromatograms Metabonomics & metabolomics Protein identification and protein characterization

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Q&A: Biosimilar Characterization: Leveraging Protein Analytical Technology within GMP Guidelines to Design a Pathway to a Successful Product