Small-Angle X-ray Scattering as a Powerful Tool for Phase and Crystallinity Assessment of Monoclonal Antibody Crystallites in Support of Batch Crystallization-Reference-Cited by-同舟云学术

Small-Angle X-ray Scattering as a Powerful Tool for Phase and Crystallinity Assessment of Monoclonal Antibody Crystallites in Support of Batch Crystallization

Published:2024-07-03 Issue:8 Volume:21 Page:4024-4037
ISSN:1543-8384
Container-title:Molecular Pharmaceutics
language:en
Short-container-title:Mol. Pharmaceutics

Author:

Larpent Patrick¹^ORCID,Codan Lorenzo²^ORCID,Bothe Jameson R.³,Iuzzolino Luca⁴^ORCID,Pabit Suzette⁵,Gupta Sudipta⁵,Fischmann Thierry⁶,Su Yongchao⁷^ORCID,Reichert Paul⁶,Stueber Dirk⁷^ORCID,Cote Aaron⁸

Affiliation:

1. Department of Analytical Research and Development, MSD Werthenstein BioPharma GmbH, Industrie Nord 1, 6105 Schachen, Switzerland

2. Department of Process Research and Development, MSD Werthenstein BioPharma GmbH, Industrie Nord 1, 6105 Schachen, Switzerland

3. Department of Analytical Research and Development, Merck & Co., Inc., Kenilworth, New Jersey 07033, United States

4. Department of Computational and Structural Chemistry, Merck & Co., Inc., Rahway, New Jersey 07065, United States

5. Department of Analytical Research and Development, Merck & Co., Inc., West Point, Pennsylvania 19486, United States

6. Department of Protein and Structural Chemistry, Merck & Co., Inc., Kenilworth, New Jersey 07033, United States

7. Department of Analytical Research and Development, Merck & Co., Inc., Rahway, New Jersey 07065, United States

8. Department of Biologics Process Research and Development, Merck & Co., Inc., Kenilworth, New Jersey 07033, United States

Publisher

American Chemical Society (ACS)

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.molpharmaceut.4c00418

Reference71 articles.

1. Monoclonal antibody therapeutics: history and future

2. Yang, M. X.; Shenoy, B.; Disttler, M.; Patel, R.; McGrath, M.; Pechenov, S.; Margolin, A. L. Anti-Sclerostin Antibody Crystals And Formulations Thereof. U.S. Patent US030,364PC, 2003.

3. Fraunhofer, W.; Borhani, D. W.; Winter, G.; Gottschalk, S. Compositions And Methods For Crystallizing Antibodies. U.S. Patent US8,753,839 B2, 2014.

4. Crystalline monoclonal antibodies for subcutaneous delivery

5. Shenoy, B.; Govardhan, C. P.; Yang, M. X.; Margolin, A. L. Crystals of Whole Antibodies and Fragments Thereof and Methods for Making and Using Them. W.O. Oatent WO072,636PC, 2002.