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New Released N-Glycan Assay Introduced
Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, have announced the launched of a new Released N-Glycan Assay for the in-depth profiling of IgG glycosylation. This new physico-chemical assay, developed by SSB’s subsidiary BioOutsource and offered in combination with its unique Antibody Dependent Cell Cytotoxicity (ADCC) assay platform, combines data on the molecular structure with a key therapeutic mechanism of action. This will generate comprehensive, highly accurate biosimilar comparability data, driving shorter drug development timelines.
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Benchtop Spectrometer Helps to Teach Students the Practical use of NMR for Spectroscopic Characterisation in Organic Chemistry
Magritek reports on the benefits of their Spinsolve Benchtop NMR spectrometer for teaching practical organic chemistry to undergraduate students at Cleveland State University in Ohio.
Dr Vania De Paoli is an associate college lecturer in the Department of Chemistry at Cleveland State University in Ohio. She is leading a program to create a solid environment for teaching Organic Chemistry. This focuses on critical thinking and analysis where every experiment is seen as a small project. The goal allows students to experience every experiment performed in lab as a (junior) scientist. Not only are synthetic skills important, but the students also need to be able to analyse their reagents and products to answer questions such as ‘does what I have made need extra purification’ or ‘what was my yield?’
Prior to investing in the Magritek benchtop NMR spectrometer, students’ practical options were limited to the measurement of melting points and refractive index. Old gas chromatographs were so old, they were no longer functional. Students were not experiencing anything close to life in a modern organic chemistry laboratory.
As Dr De Paoli says, the Spinsolve has changed this position immensely. “It is a small system, portable and lightweight. It is quickly ready to use allowing the students to have a real NMR analysis experience (they prepare the samples in standard NMR tubes, add the solvent and record the spectra in similar ways to a research grade NMR). The spectra are of good quality. The software is friendly and, overall, Spinsolve is readily affordable.”
To complement the spectrometer, Magritek provides a series of support aids to those teaching NMR. These include videos, practical experiment protocols and lab manuals. Supplied free of charge, these useful tools are available by clicking here:
http://www.magritek.com/applications/ chemistry-education/
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The new N-Glycan Assay is one of a range of orthogonal methods, including analysis by CD16a (FcγRIIIa) and SPR binding, as well as ADCC functional assays that BioOutsource offers to provide a detailed testing package to generate evidence suitable for regulatory submissions.
BioOutsource’s new assay involves enzymatically-removing glycans from the antibody, functionally derivatising them and separating the glycans by UHPLC. The glycans are then identified by on-line electrospray ionisation mass spectrometry (ESI-MS), enabling confident assignment and precise quantification of the different structures.
Dr Daniel Galbraith, Chief Scientific Officer at Sartorius Stedim BioOutsource, explained: “The structural classification and monosaccharide composition of carbohydrates attached to the constant region of therapeutic biosimilar antibodies is key to their binding. An accurate understanding of these glycans ensures effective selection of biosimilars that have the optimum ADCC activity to destroy tumour cells.”
Galbraith continued: “Our new Released N-Glycan Assay coupled with our ADCC assays will help deliver this understanding by providing robust biosimilar characterisation data suitable for the regulators, thus enabling efficient drug development and more rapid entry into clinical programs.”
To find out about BioOutsource’s new Released N-Glycan Assay and complementary
ADCC assays, scientists should go to
www.biooutsource.com/glycan-analysis/.
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