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

Qingyan Hu; Bowen Jiang; Dingjiang (Dean) Liu; Xiaolin (Charlie) Tang; Thomas Daly; Mohammed Shameem

doi:10.1007/978-3-030-31415-6_14

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

Qingyan Hu, Bowen Jiang, Dingjiang (Dean) Liu^*, Xiaolin (Charlie) Tang, Thomas Daly, Mohammed Shameem

^*Corresponding author for this work

Research output: Chapter in Book/Report/Conference proceeding › Chapter › peer-review

6 Scopus citations

Abstract

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.

Original language	English
Title of host publication	AAPS Advances in the Pharmaceutical Sciences Series
Publisher	Springer
Pages	343-372
Number of pages	30
DOIs	https://doi.org/10.1007/978-3-030-31415-6_14
State	Published - 2020
Externally published	Yes

Publication series

Name	AAPS Advances in the Pharmaceutical Sciences Series
Volume	35
ISSN (Print)	2210-7371
ISSN (Electronic)	2210-738X

Bibliographical note

Publisher Copyright:
© 2020, American Association of Pharmaceutical Scientists.

Keywords

Aggregation
Drug product development
Frozen storage stability
High concentration formulation
High protein concentration
Monoclonal antibody
Primary container selection
Solubility
Subcutaneous formulation
Viscosity reduction

ASJC Scopus subject areas

Pharmaceutical Science

Access to Document

10.1007/978-3-030-31415-6_14

Cite this

Hu, Q., Jiang, B., Liu, D., Tang, X., Daly, T., & Shameem, M. (2020). Chapter 14: Practical Considerations in High Concentration Formulation Development for Monoclonal Antibody Drug Products. In AAPS Advances in the Pharmaceutical Sciences Series (pp. 343-372). (AAPS Advances in the Pharmaceutical Sciences Series; Vol. 35). Springer. https://doi.org/10.1007/978-3-030-31415-6_14

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keywords = "Aggregation, Drug product development, Frozen storage stability, High concentration formulation, High protein concentration, Monoclonal antibody, Primary container selection, Solubility, Subcutaneous formulation, Viscosity reduction",

author = "Qingyan Hu and Bowen Jiang and Liu, {Dingjiang (Dean)} and Tang, {Xiaolin (Charlie)} and Thomas Daly and Mohammed Shameem",

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doi = "10.1007/978-3-030-31415-6_14",

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Chapter 14: Practical Considerations in High Concentration Formulation Development for Monoclonal Antibody Drug Products. / Hu, Qingyan; Jiang, Bowen; Liu, Dingjiang (Dean) et al.
AAPS Advances in the Pharmaceutical Sciences Series. Springer, 2020. p. 343-372 (AAPS Advances in the Pharmaceutical Sciences Series; Vol. 35).

Research output: Chapter in Book/Report/Conference proceeding › Chapter › peer-review

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

Abstract

Publication series

Bibliographical note

Keywords

ASJC Scopus subject areas

Access to Document

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Cite this