The Challenge of Drying Method Selection for Protein Pharmaceuticals: Product Quality Implications

Abdul‐Fattah, Ahmad M.; Kalonia, Devendra S.; Pikal, Michael J.

doi:10.1002/jps.20842

Cited by 154 publications

(94 citation statements)

References 147 publications

(274 reference statements)

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“…1 However, each method of drying generates different kinds of stresses, which can degrade proteins to various degrees during the drying processes. [1][2][3][4] Moreover, even if the optimum residual moisture, usually less than 1%, is achieved by the drying process, chemical and physical degradation such as deamidation, oxidation, and aggregation can still occur on the time scale of distribution and use. [5][6][7][8] Stability problems occurring during processing or storage are usually addressed through process and formulation optimization.…”

Section: Introductionmentioning

confidence: 99%

Mechanisms of protein stabilization in the solid state

Chang

Pikal

2009

Journal of Pharmaceutical Sciences

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Section: Introductionmentioning

confidence: 99%

Mechanisms of protein stabilization in the solid state

Chang

Pikal

2009

Journal of Pharmaceutical Sciences

Self Cite

277

208

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“…Biopharmaceuticals are often used to fight cancer, cardiovascular or diabetic diseases, or viral infections. To increase production turnover while assuring a high quality of such costly medication, the critical process parameters of the freeze-drying cycle must be optimized (2). Optimization of a freeze-drying cycle means to reduce cycle time.…”

Section: Introductionmentioning

confidence: 99%

Freeze-Dry Microscopy: Impact of Nucleation Temperature and Excipient Concentration on Collapse Temperature Data

2009

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Abstract. The objective of this study was to investigate the impact of nucleation temperature (T n ) and excipient concentration on the collapse temperature data obtained from freeze-dry microscopy (FDM) experiments. T n , the temperature of the onset of collapse (T oc ), and the full collapse temperature (T fc ) were determined for aqueous solutions of polyvinylpyrrolidone (PVP) 40 kDa and 2-(hydroxypropyl)-ß-cyclodextrin. Concentrations were varied from 1% to 20% (w/w) for PVP and from 1% to 30% (w/w) for the 2-(hydroxypropyl)-ß-cyclodextrin. Mutual correlation coefficients were calculated for the observed T n , T oc , and concentrations of the solutions. In addition, outliers were detected and eliminated by applying the leaving-one-out routine and calculating correlation coefficients without it. T n was found to be non-correlated with concentrations and only weakly correlated with T oc . The correlation between these two temperatures was particularly poor for the solutions of the highest and lowest concentrations. In contrast, T oc correlated much better with the corresponding concentrations, resulting in a quadratic fit for PVP and a linear fit for 2-(hydroxypropyl)-ß-cyclodextrin.

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“…Spray drying is often used to dry foods and ingredients that are sensitive to heat such as proteins, flavor oils, and lipid droplets (Abdul-Fattah, Kalonia, & Pikal, 2007;Ameri & Yuh-Fun, 2006;Desai & Hyun Jin, 2005). Excellent reviews exist on spray drying oils for encapsulation (Jafari, Assadpoor, He, & Bhandari, 2008;Vega & Roos, 2006).…”

Section: Spray Dryingmentioning

confidence: 99%

Structured biopolymer-based delivery systems for encapsulation, protection, and release of lipophilic compounds

2011

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Available at: https://works.bepress.com/djulian_mcclements/160/ This article appeared in a journal published by Elsevier. The attached copy is furnished to the author for internal non-commercial research and education use, including for instruction at the authors institution and sharing with colleagues. such as u-3 rich oils, conjugated linoleic acid (CLA), oil-soluble vitamins, flavors, colors, and nutraceuticals. This article provides an overview of a number of different approaches that can be used to create structured delivery systems based on biopolymers, including molecular complexation, coacervation, thermodynamic incompatibility, moulding, and extrusion methods. These delivery systems can be produced from food-grade ingredients using simple processing operations (e.g., mixing, homogenizing, and thermal processing). The structure, production, performance, and potential applications of each type of structured delivery system are discussed.

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The Challenge of Drying Method Selection for Protein Pharmaceuticals: Product Quality Implications

Cited by 154 publications

References 147 publications

Mechanisms of protein stabilization in the solid state

Mechanisms of protein stabilization in the solid state

Freeze-Dry Microscopy: Impact of Nucleation Temperature and Excipient Concentration on Collapse Temperature Data

Structured biopolymer-based delivery systems for encapsulation, protection, and release of lipophilic compounds

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