Freeze-drying for the preservation of immunoengineering products

Kommineni, Nagavendra; Butreddy, Arun; Jyothi, Vaskuri G.S. Sainaga; Angsantikul, Pavimol

doi:10.1016/j.isci.2022.105127

Cited by 11 publications

(6 citation statements)

References 111 publications

(123 reference statements)

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“…The choice of freezing procedure should consider the specific protein stability requirements to prevent conformational changes and subsequent aggregation, ultimately reducing the risk of immunogenicity. 128 During the freezing step in lyophilization, the solution is cooled to initiate ice nucleation and the growth of ice crystals. The freezing temperature is selected below the formulation glass transition temperature, and the freezing rate is chosen based on the desired ice crystal size and protein stability.…”

Section: Stabilization Strategies To Prevent Aggregation Of Protein-b...mentioning

confidence: 99%

“…However, this fast freezing approach leads to the generation of small ice crystals, which, in turn, enhances the surface area available for interactions between ice and water molecules. 128 Although the fast-freezing procedure proves beneficial for proteins prone to surface-induced conformational instability, it may not be suitable for all proteins. To illustrate this point, lactate dehydrogenase, another model protein, was employed as an example.…”

Section: Stabilization Strategies To Prevent Aggregation Of Protein-b...mentioning

confidence: 99%

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Stabilization challenges and aggregation in protein-based therapeutics in the pharmaceutical industry

Rahban,

Ahmad,

Piatyszek

et al. 2023

RSC Adv.

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Section: Stabilization Strategies To Prevent Aggregation Of Protein-b...mentioning

confidence: 99%

Section: Stabilization Strategies To Prevent Aggregation Of Protein-b...mentioning

confidence: 99%

Stabilization challenges and aggregation in protein-based therapeutics in the pharmaceutical industry

Rahban,

Ahmad,

Piatyszek

et al. 2023

RSC Adv.

View full text Add to dashboard Cite

show abstract

“…The method of freeze‐drying is also used for the preservation of immunoengineering products. [ 151 ]…”

Section: Freeze‐dried Cellsmentioning

confidence: 99%

Freeze‐Dried Mesenchymal Stem Cells: From Bench to Bedside. Review

Paresishvili,

Kakabadze

2023

Advanced Biology

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This review describes the freeze‐dried mesenchymal stem cells (MSCs) and their ability to restore damaged tissues and organs. An analysis of the literature shows that after the lyophilization MSCs retain >80% of paracrine factors and that the mechanism of their action on the restoration of damaged tissues and organs is similar to the mechanism of action of paracrine factors in fresh and cryopreserved mesenchymal stem cells. Based on the own materials, the use of paracrine factors of freeze‐dried MSCs in vivo and in vitro for the treatment of various diseases of organs and tissues has shown to be effective. The study also discusses about the advantages and disadvantages of freeze‐dried MSCs versus cryopreserved MSCs. However, for the effective use of freeze‐dried MSCs in clinical practice, a more detailed study of the mechanism of interaction of paracrine factors of freeze‐dried MSCs with target cells and tissues is required. It is also necessary to identify possible other specific paracrine factors of freeze‐dried MSCs. In addition, develop new therapeutic strategies for the use of freeze‐dried MSCs in regenerative medicine and tissue bioengineering.

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“…Lyophilization is a relatively mild drying method that improves the stability of vulnerable macrobiomolecules or colloidal nanoparticles 22,23 . However, drying of mRNA-LNPs is more sophisticated as the freezing and the dehydration process induces mechanical force and deforms the vehicle structure, leading to vehicle aggregation, mRNA breakage, or leakage 24,25 . Some studies have shown that although mRNA-LNPs maintain their integrity and encapsulation efficiency, the in vivo uptake efficacy is greatly reduced after lyophilization due to some unknown reasons 15,[26][27][28][29] .…”

Section: Introductionmentioning

confidence: 99%

Lyophilization process optimization and molecular dynamics simulation of mRNA-LNPs for SARS-CoV-2 vaccine

Li,

Jia,

Xie

et al. 2023

npj Vaccines

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Some studies have shown that lyophilization significantly improves the stability of mRNA-LNPs and enables long-term storage at 2–8 °C. However, there is little research on the lyophilization process of mRNA-lipid nanoparticles (LNPs). Most previous studies have used empirical lyophilization with only a single lyoprotectant, resulting in low lyophilization efficiency, often requiring 40–100 h. In the present study, an efficient lyophilization method suitable for mRNA-LNPs was designed and optimized, shortening the total length of the lyophilization process to 8–18 h, which significantly reduced energy consumption and production costs. When the mixed lyoprotectant composed of sucrose, trehalose, and mannitol was added to mRNA-LNPs, the eutectic point and collapse temperature of the system were increased. The lyophilized product had a ginger root-shaped rigid structure with large porosity, which tolerated rapid temperature increases and efficiently removed water. In addition, the lyophilized mRNA-LNPs rapidly rehydrated and had good particle size distribution, encapsulation rate, and mRNA integrity. The lyophilized mRNA-LNPs were stable at 2–8 °C, and they did not reduce immunogenicity in vivo or in vitro. Molecular dynamics simulation was used to compare the phospholipid molecular layer with the lyoprotectant in aqueous and anhydrous environments to elucidate the mechanism of lyophilization to improve the stability of mRNA-LNPs. This efficient lyophilization platform significantly improves the accessibility of mRNA-LNPs.

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Freeze-drying for the preservation of immunoengineering products

Cited by 11 publications

References 111 publications

Stabilization challenges and aggregation in protein-based therapeutics in the pharmaceutical industry

Stabilization challenges and aggregation in protein-based therapeutics in the pharmaceutical industry

Freeze‐Dried Mesenchymal Stem Cells: From Bench to Bedside. Review

Lyophilization process optimization and molecular dynamics simulation of mRNA-LNPs for SARS-CoV-2 vaccine

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