[RETRACTED ARTICLE] Analytical Method Development and Validation of Purity in Nimotuzumab Products

Authors

  • Chanida Karnpracha Department of Medical Science, Ministry of Public Health
  • Soraya Surasarang Department of Medical Science, Ministry of Public Health

Keywords:

Aggregate, Nimotuzumab, Size exclusion chromatography

Abstract

The decision to retract this article was made after the authors identified the presence of certain sensitive that cannot be disclosed or published in any form. We sincerely apologize for any inconvenience this may cause and greatly appreciate your understanding. The authors recognize that the scientific community takes such matters very seriously and wish to extend their apologies to the readers of the journal for not identifying this issue during the submission and review process.

References

Ruei-Min Lu, Yu-Chyi Hwang, I-Ju Liu, Chi-Chiu Lee, Han-Zen Tsai, Hsin-Jung Li and Han-Chung

Wu. Development of therapeutic antibodies for the treatment of diseases. Journal of Biomedical

Science. 27, Article number: 1 (2020).

Yunyu (Linda) Yi and Li Zang. Protein aggregation and its inhibition in bio-pharmaceutics. Int J

Pharm. 289 (1-2): 1-30.

TheraCIM Nimotuzumab Injection solution. http://www.theracim-nimotuzumab.com/wp- content/uploads/2018/09/Insert-Theracim-Thailand.pdf. Accessed on 20/7/2022.

International Conference on Harmonisation (ICH) of Technical Requirements for Registration of

Pharmaceuticals for Human Use. Validation of Analytical Procedures: Text and Methodology

Q2R (1), November 2005.

Appendix F: Guidelines for Standard Method Performance Requirements, AOAC Official Methods of

Analysis. 2016. AOAC INTERNATIONAL, Gaithersburg, MD, USA. [cited on 2020 Oct 14].

Available from: http://www.eoma.aoac.org/app_f.pdf.

Hamrang Z, Rattray NJW, Pluen A. Proteins behaving badly: emerging technologies in profiling

biopharmaceutical aggregation. Trends Biotechnol., 31 (8) (2013), pp. 448-458.

Ratanji KD, Derrick JP, Dearman RJ, Kimber I, Immunogenicity of therapeutic proteins: influence of

aggregation, J. Immunotoxicol. 11 (2). 2014; 99–109.

Moussa EM, Panchal JP, Moorthy BS, Blum JS, Joubert MK, Narhi LO, Topp EM, Immunogenicity of

therapeutic protein aggregates, J. Pharm. Sci. 105 (2). 2016; 417–430.

Hernández-Jiménez J, Martínez-Ortega A, Salmerón-García A, Cabeza J, Prados JC, Ortíz R, Navas N

Study of aggregation in therapeutic monoclonal antibodies subjected to stress and long-term

stability tests by analyzing size exclusion liquid chromatographic profiles, International Journal

of Biological Macromolecules, 118 (A), 2018; 511-524

Tan Z, Ehamparanathan V, Ren T, Tang P, Hoffman L, Kuang J et. al. On-column disulfide bond

formation of monoclonal antibodies during Protein A chromatography eliminates low molecular

weight species and rescues reduced antibodies, mAbs, 12.2020:1.

Sepax Technologies, Inc. User Manual. UM001, Ver.20210624. Available from: https://www.sepax-

tech.com/usermanual/UserManual_TweenTrap.pdf. [Accessed on 10 Jan 2022].

Downloads

Published

2025-03-04