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

Published

April 12, 2022

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

NIST Pub Series

Special Publication (NIST SP)

Pub Type

NIST Pubs

Download Paper

https://doi.org/10.6028/NIST.SP.260-224

Local Download

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 March 4, 2025)