Properties of protein formulations

Henryk Mach; Brian K. Meyer; Mohammed Shameem

doi:10.1533/9781908818102.47

Properties of protein formulations

Henryk Mach^*, Brian K. Meyer, Mohammed Shameem

^*Corresponding author for this work

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

2 Scopus citations

Abstract

During the development of therapeutic protein drug product formulations, factors such as opalescence, phase separation, and the presence of subvisible particles need to be considered in addition to stability. These factors can influence the physical appearance, manufacturability, and potential for immunogenicity. An overview of how these phenomena can be detected, measured, and mitigated during formulation development is presented.

Original language	English
Title of host publication	Therapeutic Protein Drug Products
Subtitle of host publication	Practical Approaches to formulation in the Laboratory, Manufacturing, and the Clinic
Publisher	Elsevier Ltd.
Pages	47-65
Number of pages	19
ISBN (Print)	9781907568183
DOIs	https://doi.org/10.1533/9781908818102.47
State	Published - Jan 2012
Externally published	Yes

Keywords

HIAC
Imaging
Obscuration
Opalescence
Phase separation
Standards
Subvisible particles

ASJC Scopus subject areas

General Dentistry
General Medicine

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10.1533/9781908818102.47

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title = "Properties of protein formulations",

abstract = "During the development of therapeutic protein drug product formulations, factors such as opalescence, phase separation, and the presence of subvisible particles need to be considered in addition to stability. These factors can influence the physical appearance, manufacturability, and potential for immunogenicity. An overview of how these phenomena can be detected, measured, and mitigated during formulation development is presented.",

keywords = "HIAC, Imaging, Obscuration, Opalescence, Phase separation, Standards, Subvisible particles",

author = "Henryk Mach and Meyer, \{Brian K.\} and Mohammed Shameem",

year = "2012",

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doi = "10.1533/9781908818102.47",

language = "English",

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pages = "47--65",

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T1 - Properties of protein formulations

AU - Mach, Henryk

AU - Meyer, Brian K.

AU - Shameem, Mohammed

PY - 2012/1

Y1 - 2012/1

N2 - During the development of therapeutic protein drug product formulations, factors such as opalescence, phase separation, and the presence of subvisible particles need to be considered in addition to stability. These factors can influence the physical appearance, manufacturability, and potential for immunogenicity. An overview of how these phenomena can be detected, measured, and mitigated during formulation development is presented.

AB - During the development of therapeutic protein drug product formulations, factors such as opalescence, phase separation, and the presence of subvisible particles need to be considered in addition to stability. These factors can influence the physical appearance, manufacturability, and potential for immunogenicity. An overview of how these phenomena can be detected, measured, and mitigated during formulation development is presented.

KW - HIAC

KW - Imaging

KW - Obscuration

KW - Opalescence

KW - Phase separation

KW - Standards

KW - Subvisible particles

UR - https://www.scopus.com/pages/publications/84904234471

U2 - 10.1533/9781908818102.47

DO - 10.1533/9781908818102.47

M3 - Chapter

AN - SCOPUS:84904234471

SN - 9781907568183

SP - 47

EP - 65

BT - Therapeutic Protein Drug Products

PB - Elsevier Ltd.

ER -

Properties of protein formulations

Abstract

Keywords

ASJC Scopus subject areas

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Cite this