Lyophilization‐induced protein denaturation in phosphate buffer systems: Monomeric and tetrameric β‐galactosidase

Pikal-Cleland, Katherine; Carpenter, John F.

doi:10.1002/jps.1078

Cited by 81 publications

(52 citation statements)

References 37 publications

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“…4). 1,8 Both monomeric and tetrameric b-gal displayed a significant loss in activity after freeze-thawing (slow cooling/slow warming) in the NaP buffer system, with a pH decrease from 7.0 to 5.5 and 3.8 in the frozen state for the 10 and 100 mM NaP buffers, respectively. A greater extent of buffer salt crystallization occurs when freezing at a higher initial buffer concentration (100 mM NaP), thus resulting in a more pronounced pH shift.…”

Section: Effects Of Glycine On Protein Stabilitymentioning

confidence: 99%

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Effect of Glycine on pH Changes and Protein Stability During Freeze–Thawing in Phosphate Buffer Systems

Pikal-Cleland

Cleland²,

Anchordoquy

et al. 2002

Journal of Pharmaceutical Sciences

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115

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Section: Effects Of Glycine On Protein Stabilitymentioning

confidence: 99%

“…1,3,8 However, the presence of a commonly used excipient, such as glycine, in phosphate buffers might significantly influence the pH of the frozen solution. Therefore, we chose to examine the thermal and pH history of glycine/phosphate formulations ( Fig.…”

Section: Effect Of Glycine On Ph In the Frozen Statementioning

confidence: 99%

Effect of Glycine on pH Changes and Protein Stability During Freeze–Thawing in Phosphate Buffer Systems

Pikal-Cleland

Cleland²,

Anchordoquy

et al. 2002

Journal of Pharmaceutical Sciences

Self Cite

115

View full text Add to dashboard Cite

“…The appropriate formulation becomes critical when bulk freezing and thawing is required, and excipients may serve as protein cryo-protectants (Pikal-Cleland and Carpenter, 2001).…”

Section: How To Minimize Aggregates Formation During Mab Processingmentioning

confidence: 99%

Aggregates in monoclonal antibody manufacturing processes

Vázquez-Rey¹,

Lang

2011

Biotech & Bioengineering

406

304

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Monoclonal antibodies have proved to be a highly successful class of therapeutic products. Large-scale manufacturing of pharmaceutical antibodies is a complex activity that requires considerable effort in both process and analytical development. If a therapeutic protein cannot be stabilized adequately, it will lose partially or totally its therapeutic properties or even cause immunogenic reactions thus potentially further endangering the patients' health. The phenomenon of protein aggregation is a common issue that compromises the quality, safety, and efficacy of antibodies and can happen at different steps of the manufacturing process, including fermentation, purification, final formulation, and storage. Aggregate levels in drug substance and final drug product are a key factor when assessing quality attributes of the molecule, since aggregation might impact biological activity of the biopharmaceutical. In this review it is analyzed how aggregates are formed during monoclonal antibody industrial production, why they have to be removed and the manufacturing process steps that are designed to either minimize or remove aggregates in the final product.

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“…In lyophilization course, usage of cryoprotector may reduce or even prevent influence of stress on activity of protein 57) . Silk protein and chitsan can be used as cryoprotector to well maintain activity of VEGF 58,59) . Alexander proved that conformation of protein treated with low concentration methanoll was basically not changed and covalent structure of protein molecule was not destroyed 60) .…”

Section: Discussionmentioning

confidence: 99%

<i>In Vitro</i> Culture of BMSCs on VEGF-SF-CS Three-Dimensional Scaffolds for Bone Tissue Engineering

Tong

Xue

et al. 2015

J. Hard Tissue Biology.

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The objective of the study was to discuss the biocompatibility of VEGF-silk fibroin-chitosan (VEGF-SF-CS) three-dimensional scaffolds in order to offer an ideal scaffold for bone tissue engineering. Bone marrow derived mesenchymal stem cells (BMSCs) were seeded on the VEGF-SF-CS three-dimensional scaffolds and silk fibroin-chitosan (SF-CS) three-dimensional scaffolds. On VEGF-SF-CS and SF-CS three-dimensional scaffolds, the cell adhesion rate was increased as time went on. Scanning electron microscopy: The cells grew actively and had normal multiple fissions, granular and filamentous substrates could be seen around the cells, and cell microfilaments were closely connected with the scaffolds. The cells could not only show attached growth on surfaces of the scaffolds, but could also extend into the scaffolds. CCK-8 and ALP analysis proved that the vascular endothelial growth factor (VEGF) could significantly promote BMSCs growth and proliferation in the SF-CS scaffolds; however, the enhancement of BMSCs cell proliferation and activity by VEGF is dependent on time. Thus, VEGF-SF-CS composite scaffolds represent a promising new type of scaffold for bone tissue engineering.

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Lyophilization‐induced protein denaturation in phosphate buffer systems: Monomeric and tetrameric β‐galactosidase

Cited by 81 publications

References 37 publications

Effect of Glycine on pH Changes and Protein Stability During Freeze–Thawing in Phosphate Buffer Systems

Effect of Glycine on pH Changes and Protein Stability During Freeze–Thawing in Phosphate Buffer Systems

Aggregates in monoclonal antibody manufacturing processes

<i>In Vitro</i> Culture of BMSCs on VEGF-SF-CS Three-Dimensional Scaffolds for Bone Tissue Engineering

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