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Physical Stability of Proteins in Aqueous Solution: Mechanism and Driving Forces in Nonnative Protein Aggregation
Irreversible protein aggregation is problematic in the biotechnology industry, where aggregation is encountered throughout the lifetime of a therapeutic protein, including during refolding,Expand
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  • Open Access
The ice nucleation temperature determines the primary drying rate of lyophilization for samples frozen on a temperature-controlled shelf.
The objective of this study was to determine the influence of ice nucleation temperature on the primary drying rate during lyophilization for samples in vials that were frozen on a lyophilizer shelf.Expand
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Rational Design of Stable Lyophilized Protein Formulations: Some Practical Advice
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Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality.
Therapeutic protein products provide unique and effective treatments for numerous human diseases and medical conditions. In many cases, these treatments are used chronically to slow diseaseExpand
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Annealing to optimize the primary drying rate, reduce freezing-induced drying rate heterogeneity, and determine T(g)' in pharmaceutical lyophilization.
In a companion paper we show that the freezing of samples in vials by shelf-ramp freezing results in significant primary drying rate heterogeneity because of a dependence of the ice crystal size onExpand
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Hydrogen bonding between sugar and protein is responsible for inhibition of dehydration-induced protein unfolding.
The nature of the interaction responsible for the inhibition of protein unfolding and subsequent damage by sugars during dehydration is unclear. The relationship between sample moisture contentExpand
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Effects of Tween 20 and Tween 80 on the stability of Albutropin during agitation.
The objectives of this work were to determine the effects of nonionic surfactants (Tween 20 and Tween 80) on agitation-induced aggregation of the recombinant fusion protein, Albutropintrade markExpand
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Protein formulation and lyophilization cycle design: prevention of damage due to freeze-concentration induced phase separation.
Hemoglobin has been previously shown to unfold during freeze drying when lyophilized from formulations that undergo freeze-concentration induced phase separation (Heller et al. 1997. Biotechnol ProgExpand
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Oxidative dimer formation is the critical rate-limiting step for Parkinson's disease alpha-synuclein fibrillogenesis.
Intraneuronal deposition of alpha-synuclein as fibrils and oxidative stress are both implicated in the pathogenesis of Parkinson's disease. We found that the critical rate-limiting step in nucleationExpand
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Roles of conformational stability and colloidal stability in the aggregation of recombinant human granulocyte colony‐stimulating factor
We studied the non‐native aggregation of recombinant human granulocyte stimulating factor (rhGCSF) in solution conditions where native rhGCSF is both conformationally stable compared to its unfoldedExpand
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