Chapter 14: Practical Considerations in High Concentration Formulation Development for Monoclonal Antibody Drug Products

Autor: Bowen Jiang, Thomas Daly, Xiaolin Tang, Dingjiang Liu, Qingyan Hu, Mohammed Shameem
Rok vydání: 2020
Předmět:
Zdroj: Development of Biopharmaceutical Drug-Device Products ISBN: 9783030314149
Popis: This book chapter covers practical consideration and strategies in developing high concentration formulations and drug products for commercial use. The discussions presented in this chapter are based on authors’ hands-on experience supplemented with literature findings, and focus on formulation and analytical aspects, as well as primary container considerations unique for high concentration formulation development.
Databáze: OpenAIRE