Impact of sucrose level on storage stability of proteins in freeze-dried solids: II. Correlation of aggregation rate with protein structure and molecular mobility**This work is a product of the U.S. Government and is not subject to copyright in the United States.

Wang, Bingquan; Tchessalov, Serguei; Cicerone, Marcus T.; Warne, Nicholas W.; Pikal, Michael J.

doi:10.1002/jps.21622

Cited by 107 publications

(138 citation statements)

References 60 publications

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“…protein, lipid and DNA), the continuum assumption is not applicable. In this range, on which we do not focus in this paper, mathematical models follow molecular dynamics (Bromfield et al 2009;Wang et al 2009). …”

Section: (C) Mass Transport Across Cell Membranementioning

confidence: 99%

Multi-scale heat and mass transfer modelling of cell and tissue cryopreservation

Moon

Zhang

et al. 2010

Phil. Trans. R. Soc. A.

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Cells and tissues undergo complex physical processes during cryopreservation. Understanding the underlying physical phenomena is critical to improve current cryopreservation methods and to develop new techniques. Here, we describe multiscale approaches for modelling cell and tissue cryopreservation including heat transfer at macroscale level, crystallization, cell volume change and mass transport across cell membranes at microscale level. These multi-scale approaches allow us to study cell and tissue cryopreservation.

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Section: (C) Mass Transport Across Cell Membranementioning

confidence: 99%

Multi-scale heat and mass transfer modelling of cell and tissue cryopreservation

Moon

Zhang

et al. 2010

Phil. Trans. R. Soc. A.

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“…Additionally, there is increasing evidence of their role in protein stabilization. Mechanisms proposed suggest stabilization by plasticization of the amorphous glass to dampen molecular motions (also called 'fast dynamics') during thermal exposure [71,72].…”

Section: Other Formulation Componentsmentioning

confidence: 99%

Stabilization Challenges and Formulation Strategies Associated with Oral Biologic Drug Delivery Systems

Truong‐Le¹,

Lovalenti²,

Abdul‐Fattah³

2015

Advanced Drug Delivery Reviews

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“…In the solid state, protein aggregation appears more often to follow the Arrhenius relationship (50,51). It was found that the rate of aggregation for a mAb in lyophilized formulations at several different moisture levels followed Arrhenius kinetics between 5 and 50 C in the glassy state (well below the effective glass transition temperature (T g )) (52).…”

Section: Protein Aggregation and Its Temperature Dependencementioning

confidence: 99%

Non-Arrhenius Protein Aggregation

Wang

Roberts

2013

AAPS J

126

109

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Abstract. Protein aggregation presents one of the key challenges in the development of protein biotherapeutics. It affects not only product quality but also potentially impacts safety, as protein aggregates have been shown to be linked with cytotoxicity and patient immunogenicity. Therefore, investigations of protein aggregation remain a major focus in pharmaceutical companies and academic institutions. Due to the complexity of the aggregation process and temperature-dependent conformational stability, temperature-induced protein aggregation is often non-Arrhenius over even relatively small temperature windows relevant for product development, and this makes low-temperature extrapolation difficult based simply on accelerated stability studies at high temperatures. This review discusses the non-Arrhenius nature of the temperature dependence of protein aggregation, explores possible causes, and considers inherent hurdles for accurately extrapolating aggregation rates from conventional industrial approaches for selecting accelerated conditions and from conventional or more advanced methods of analyzing the resulting rate data.

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Impact of sucrose level on storage stability of proteins in freeze-dried solids: II. Correlation of aggregation rate with protein structure and molecular mobility**This work is a product of the U.S. Government and is not subject to copyright in the United States.

Cited by 107 publications

References 60 publications

Multi-scale heat and mass transfer modelling of cell and tissue cryopreservation

Multi-scale heat and mass transfer modelling of cell and tissue cryopreservation

Stabilization Challenges and Formulation Strategies Associated with Oral Biologic Drug Delivery Systems

Non-Arrhenius Protein Aggregation

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