Quantification of an intact monoclonal antibody, rituximab, by (RP)HPLC/DAD in compliance with ICH guidelines

Author:

Navas Natalia,Herrera Agustín,Martínez-Ortega Antonio,Salmerón-García Antonio,Cabeza José,Cuadros-Rodríguez Luis

Publisher

Springer Science and Business Media LLC

Subject

Biochemistry,Analytical Chemistry

Reference43 articles.

1. Strohl WR (2009) In: Zhiqiang A (ed) Therapeutic monoclonal antibodies: from bench to clinic. Wiley, Hoboken

2. Crommelin DJA, Storm G, Verrijk R, de Leede I, Jiskot W, Hennik WE (2003) Shifting paradigms; biopharmaceuticals versus low molecular weight drugs. Int J Pharm 266:3–16

3. Staub A, Guillarme D, Schappler J, Veuthey JL, Rudaz S (2011) Intact protein analysis in the biopharmaceutical field. J Pharm Biomed Anal 55:810–822

4. ICH Secretariat (1999) International Conference on Harmonization (ICH) guideline ICH Q6B: specifications: test procedures and acceptance criteria for biotechnological/biological products. ICH Secretariat, Geneva

5. ICH Secretariat (2005) International Conference on Harmonization (ICH) guideline ICH Q2(R1): validation of analytical procedures: text and methodology. ICH Secretariat, Geneva

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