Chapter 14: Practical Considerations in High Concentration Formulation Development for Monoclonal Antibody Drug Products
- Resource Type
- Authors
- Bowen Jiang; Thomas Daly; Xiaolin Tang; Dingjiang Liu; Qingyan Hu; Mohammed Shameem
- Source
- Development of Biopharmaceutical Drug-Device Products ISBN: 9783030314149
- Subject
- Drug
High concentration
Focus (computing)
Computer science
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Container (abstract data type)
Biochemical engineering
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- Language
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.