The effect of residual moisture on a monoclonal antibody stability in L-arginine based lyophilisates

Author:

Seifert Ivonne,Friess Wolfgang

Publisher

Elsevier BV

Subject

Pharmaceutical Science,General Medicine,Biotechnology

Reference28 articles.

1. Freeze-Drying of Proteins;Pikal,1994

2. Rational Design of Stable Lyophilized Protein Formulations: Theorey and Practice;Carpenter,2002

3. Stabilization of Proteins in Solid Form;Cicerone;Adv. Drug Del. Rev.,2015

4. Effects of buffer composition and processing conditions on aggregation of bovine IgG during freeze-drying;Sarciaux;J. Pharm. Sci.,1999

5. Chang, B.S. and S.Y. Patro, Freeze-drying Process Development for Protein Pharmaceuticals, in Lyophilization of Biopharmaceuticals, H.R. Costantino and M. Pikal, Editors. 2004, American Association of Pharmaceutical Scientists. p. 113-138.

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1. Effects of arginine in therapeutic protein formulations: a decade review and perspectives;Antibody Therapeutics;2023-10-01

2. Predicting the amorphous-phase composition during lyophilization;International Journal of Pharmaceutics;2023-04

3. Formulation Design for Freeze-Drying: Case Studies of Stabilization of Proteins;Principles and Practices of Lyophilization in Product Development and Manufacturing;2023

4. In-vial printing and drying of biologics as a personalizable approach;International Journal of Pharmaceutics;2022-07

5. One step synthesis of an amino acid derived particles, poly( L‐Arginine ) and its biomedical application;Polymers for Advanced Technologies;2021-11-24

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