Ice Recrystallization in a Solution of a Cryoprotector and Its Inhibition by a Protein: Synchrotron X-Ray Diffraction Study

Zakharov, Boris A.; Fisyuk, A. S.; Fitch, Andy; Watier, Yves; Kostyuchenko, Anastasia S.; Varshney, Dushyant; Sztucki, Michael; Болдырева, Е. В.; Shalaev, Evgenyi

doi:10.1016/j.xphs.2016.04.020

Cited by 19 publications

(13 citation statements)

References 68 publications

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“…For example, it was suggested that the observations of freeze-induced protein destabilization do not necessarily prove that there is a direct ice/protein interaction ( i.e. , sorption of protein molecules on ice crystals), as the same results could be explained by a partitioning of protein into quasi-liquid layer (52). The quasi-liquid layer (also known as liquid-like layer) is a thin film of liquid water on the surface of ice crystals, which exists well below the ice melting temperature even in pure water (53).…”

Section: Interfacial Stress In Drug Substance Developmentmentioning

confidence: 99%

Interfacial Stress in the Development of Biologics: Fundamental Understanding, Current Practice, and Future Perspective

Li¹,

Krause

Chen

et al. 2019

AAPS J

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100

102

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Biologic products encounter various types of interfacial stress during development, manufacturing, and clinical administration. When proteins come in contact with vapor–liquid, solid–liquid, and liquid–liquid surfaces, these interfaces can significantly impact the protein drug product quality attributes, including formation of visible particles, subvisible particles, or soluble aggregates, or changes in target protein concentration due to adsorption of the molecule to various interfaces. Protein aggregation at interfaces is often accompanied by changes in conformation, as proteins modify their higher order structure in response to interfacial stresses such as hydrophobicity, charge, and mechanical stress. Formation of aggregates may elicit immunogenicity concerns; therefore, it is important to minimize opportunities for aggregation by performing a systematic evaluation of interfacial stress throughout the product development cycle and to develop appropriate mitigation strategies. The purpose of this white paper is to provide an understanding of protein interfacial stability, explore methods to understand interfacial behavior of proteins, then describe current industry approaches to address interfacial stability concerns. Specifically, we will discuss interfacial stresses to which proteins are exposed from drug substance manufacture through clinical administration, as well as the analytical techniques used to evaluate the resulting impact on the stability of the protein. A high-level mechanistic understanding of the relationship between interfacial stress and aggregation will be introduced, as well as some novel techniques for measuring and better understanding the interfacial behavior of proteins. Finally, some best practices in the evaluation and minimization of interfacial stress will be recommended.

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Section: Interfacial Stress In Drug Substance Developmentmentioning

confidence: 99%

Interfacial Stress in the Development of Biologics: Fundamental Understanding, Current Practice, and Future Perspective

Li¹,

Krause

Chen

et al. 2019

AAPS J

Self Cite

100

102

View full text Add to dashboard Cite

show abstract

“…Поширеною думкою є твердження, що сироватка «стабілізує» мембрани під час кріоконсервування, попереджує їхнє осмотичне пошкодження, захищає клітини від дії вільних радикалів, проте механізм цього захисту залишається нез'ясованим [25]. Механізм кріопротекторної дії сироватки пов'язують із наявністю протеїнів плазми, що мають дію непроникальних кріопротекторів під час кріоконсервування [26,27].…”

Section: загальна збереженість (25%~75%)unclassified

Use of polyethyleneoxide and hydroxyethylstarch as blood plasma substitutes in the cryopreservation of testis interstitium cells in mice

Pakhomov

Grabovetskaya

Філімонова

et al. 2020

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Purpose of the study: to investigate the impact of hydroxyethyl starch (HES) and polyethylene oxide (PEO) on the indicators of preservation of murine testis interstitial cells (IC) under cryopreservation.Materials and methods. To isolate IC the enzymes were used: 0.2 mg/ml collagenase and 0.1 mg/ml DNase. The obtained cell suspension was cryopreserved in the solutions that contained 0; 0,7; 1,4; 2,1; 2,8 M of dimethyl sulfoxide (DMSO) and/or 10%, 20% fetal cow serum, 10 mg/ml PEO or HES. The samples (1 ml) were cooled at a rate of 1 °C/min to -80 °C then stored in liquid nitrogen (-196 °C). They were warmed at 37 °C in the water bath. Cryopreservation solution was removed. The number of cells and their preservation were assessed before and after with the assistance of Goryaev’s camera. Viability of IC, Leydig cell preservation and preservation of metabolic activity were measured with trypan blue dye, histochemical staining for 3β-hydroxysteroid dehydrogenase activity.Results. It was shown that 1,4 M DMSO without supplements favored IC preservation. Addition to the cryopreservation solution 10% and 20% of fetal cow serum or 10 mg/ml HES increased total preservation of IC by more than 10% and Leydig cell cryopreservation by an average 15%. HES 10 mg/ml may decrease DMSO concentration to 0,7 M. This combination had the best indicators of total preservation of IC, preservation of viable cells and Leydig cells: 75,8 (53,3; 93,3), 55,6 (45,1; 69,4), 57,1 (40,2;70,3) %, respectively. PEO was ineffective.Conclusion. High-molecular weight synthetic polymers such as HES can substitute protective properties of blood serum under cryopreservation and allow decreasing effective concentration of permeable cryoprotective such as DMSO.

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“…41,42 Scattering has been used to obtain crystal structures of cryoprotectants such as AFPs, 43 though little research has been taken into their effect on ice growth. 44 Studies have also monitored crystallization, polymorphism and disorder of ice upon addition of solutes such as bovine serum albumin (BSA) and sorbitol 45,46 as well as investigating potential ice growth inhibition mechanisms. 47 However XRD has not been used thus far to study the kinetics of ice growth, which is crucial in the design of new IRIs.…”

Section: Introductionmentioning

confidence: 99%

X-ray diffraction to probe the kinetics of ice recrystallization inhibition

Fayter

Huband

Gibson

2020

Analyst

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Ice Recrystallization in a Solution of a Cryoprotector and Its Inhibition by a Protein: Synchrotron X-Ray Diffraction Study

Cited by 19 publications

References 68 publications

Interfacial Stress in the Development of Biologics: Fundamental Understanding, Current Practice, and Future Perspective

Interfacial Stress in the Development of Biologics: Fundamental Understanding, Current Practice, and Future Perspective

Use of polyethyleneoxide and hydroxyethylstarch as blood plasma substitutes in the cryopreservation of testis interstitium cells in mice

X-ray diffraction to probe the kinetics of ice recrystallization inhibition

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