Heterologous recombinant expression of non-originator NISTmAb

被引:3
|
作者
Kashi, Lila [1 ,2 ]
Yandrofski, Katharina [3 ]
Preston, Renae J. [1 ,2 ]
Arbogast, Luke W. [3 ]
Giddens, John P. [3 ]
Marino, John P. [3 ]
Schiel, John E. [3 ]
Kelman, Zvi [1 ,2 ]
机构
[1] Univ Maryland, Biomol Labeling Lab, NIST, 9600 Gudelsky Dr, Rockville, MD 20850 USA
[2] Univ Maryland, Inst Biosci & Biotechnol Res, 9600 Gudelsky Dr, Rockville, MD 20850 USA
[3] NIST, Inst Biosci & Biotechnol Res, Rockville, MD USA
关键词
Biopharmaceutical; biosimilar; biotherapeutic; mass spectrometry; monoclonal antibody; NISTmAb; NMR; HIGHER-ORDER STRUCTURE; SMALL-ANGLE SCATTERING; MONOCLONAL-ANTIBODY; MOLECULAR SIMULATION; NATURAL-ABUNDANCE; PROTEIN; NMR; CHROMATOGRAPHY; THERAPEUTICS; SIMILARITY;
D O I
10.1080/19420862.2018.1486355
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
The successful development and regulatory approval of originator and biosimilar therapeutic proteins requires a systems approach to upstream and downstream processing as well as product characterization and quality control. Innovation in process design and control, product characterization strategies, and data integration represent an ecosystem whose concerted advancement may reduce time-to-market and further improve comparability and biosimilarity programs. The biopharmaceutical community has made great strides to this end, yet there currently exists no pre-competitive monoclonal antibody (mAb) expression platform for open innovation. Here, we describe the development and initial expression of an intended copy of the NISTmAb using three non-originator murine cell lines. It was found that, without optimization and in culture flasks, all three cell lines produce approximately 100mg mAb per liter of culture. Sodium dodecyl sulfate polyacrylamide gel electrophoresis, size-exclusion chromatography, nuclear magnetic resonance spectroscopy, intact mass spectrometry, and surface plasmon resonance were used to demonstrate that the products of all three cell lines embody quality attributes with a sufficient degree of sameness to the NISTmAb Reference Material 8671 to warrant further bioreactor studies, process improvements and optimization. The implications of the work with regard to pre-competitive innovation to support process design and feedback control, comparability and biosimilarity assessments, and process analytical technologies are discussed.
引用
收藏
页码:922 / 933
页数:12
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