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Certification of Standard Reference Material® 3655 Glycans in Solution (Frozen)

Published

Author(s)

Mark Lowenthal, Blaza Toman, Brian Lang, Karen W. Phinney

Abstract

Standard Reference Material (SRM) 3655 is intended primarily for use as a calibration standard for the measurement of enzymatically released N-linked glycans. Applications of SRM 3655 include the benchmarking and comparability of analytical techniques, as a material for ensuring system suitability, and for analytical method validation. This material may also be used to value-assign in-house calibrators or control materials. SRM 3655 consists of thirteen (13) aqueous solutions of glycans commonly associated with monoclonal antibody therapeutics. Each solution contains a purified, free-reducing glycan at a defined mass fraction. A unit of SRM 3655 consists of thirteen 0.5 mL vials each containing approximately 0.2 mL of solution, frozen and stored at -80 °C. The tube is labeled and is sealed with a color-coded screw cap with a Teflon liner. This publication documents the production, analytical methods, measurement results, and statistical evaluations involved in characterizing these glycan materials.
Citation
Special Publication (NIST SP) - 260-224
Report Number
260-224

Keywords

Glycans, N-linked glycosylation, monoclonal antibody therapeutics, Standard Reference Material (SRM)

Citation

Lowenthal, M. , Toman, B. , Lang, B. and Phinney, K. (2022), Certification of Standard Reference Material® 3655 Glycans in Solution (Frozen), Special Publication (NIST SP), National Institute of Standards and Technology, Gaithersburg, MD, [online], https://doi.org/10.6028/NIST.SP.260-224, https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=934355 (Accessed June 29, 2022)
Created April 12, 2022