| Title |
Qualification of NISTmAb charge heterogeneity control assays
|
|---|---|
| Published in |
Analytical & Bioanalytical Chemistry, February 2018
|
| DOI | 10.1007/s00216-017-0816-6 |
| Pubmed ID | |
| Authors |
Abigail Turner, John E. Schiel |
| Abstract |
The NISTmAb is a monoclonal antibody Reference Material from the National Institute of Standards and Technology; it is a class-representative IgG1κ intended serve as a pre-competitive platform for harmonization and technology development in the biopharmaceutical industry. The publication series of which this paper is a part describes NIST's overall control strategy to ensure NISTmAb quality and availability over its lifecycle. In this paper, the development and qualification of methods for monitoring NISTmAb charge heterogeneity are described. Capillary zone electrophoresis (CZE) and capillary isoelectric focusing (CIEF) assays were optimized and evaluated as candidate assays for NISTmAb quality control. CIEF was found to be suitable as a structural characterization assay yielding information on the apparent pI of the NISTmAb. CZE was found to be better suited for routine monitoring of NISTmAb charge heterogeneity and was qualified for this purpose. This paper is intended to provide relevant details of NIST's charge heterogeneity control strategy to facilitate implementation of the NISTmAb as a test molecule in the end user's laboratory. Graphical Abstract Representative capillary zone electropherogram of the NIST monoclonal antibody (NISTmAb). The NISTmAb is a publicly available research tool intended to facilitate advancement of biopharmaceutical analytics. |
X Demographics
The data shown below were collected from the profile of 1 X user who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Scientists | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 65 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 65 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 14 | 22% |
| Student > Ph. D. Student | 13 | 20% |
| Student > Master | 8 | 12% |
| Student > Bachelor | 5 | 8% |
| Student > Doctoral Student | 3 | 5% |
| Other | 6 | 9% |
| Unknown | 16 | 25% |
| Readers by discipline | Count | As % |
|---|---|---|
| Chemistry | 13 | 20% |
| Biochemistry, Genetics and Molecular Biology | 13 | 20% |
| Pharmacology, Toxicology and Pharmaceutical Science | 9 | 14% |
| Engineering | 2 | 3% |
| Computer Science | 2 | 3% |
| Other | 4 | 6% |
| Unknown | 22 | 34% |
Attention Score in Context
This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 28 February 2018.
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