Surface Treatment of Glass Vials for Lyophilization: Implications for Vacuum-Induced Surface Freezing

Regis, Francesco; Arsiccio, Andrea; Bourlés, Erwan; Scutellà, Bernadette; Pisano, Roberto

doi:10.3390/pharmaceutics13111766

Cited by 9 publications

(10 citation statements)

References 41 publications

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“…The RMC of the NDV-VFD vaccine was detected using thermogravimetric analysis (Merivaara et al 2021 ; Osman et al 2021 ; Regis et al 2021 ). To determine the RMC after drying, eight vials of each vaccine preparation were weighed before and after drying at 80℃ for 2 h without a stopper.…”

Section: Methodsmentioning

confidence: 99%

Thermostable vacuum foam dried Newcastle disease vaccine: Process optimization and pilot-scale study

Lyu,

Zhao,

Zuo

et al. 2024

Appl Microbiol Biotechnol

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Vacuum foam drying (VFD) has been shown to improve the thermostability and long-term shelf life of Newcastle Disease Virus (NDV). This study optimized the VFD process to improve the shelf life of NDV at laboratory-scale and then tested the optimized conditions at pilot-scale. The optimal NDV to T5 formulation ratio was determined to be 1:1 or 3:2. Using the 1:1 virus to formulation ratio, the optimal filling volumes were determined to be 13–17% of the vial capacity. The optimized VFD process conditions were determined to be at a shelf temperature of 25℃ with a minimum overall drying time of 44 h. The vaccine samples prepared using these optimized conditions at laboratory-scale exhibited virus titer losses of ≤ 1.0 log10 with residual moisture content (RMC) below 3%. Furthermore, these samples were transported for 97 days around China at ambient temperature without significant titer loss, thus demonstrating the thermostability of the NDV-VFD vaccine. Pilot-scale testing of the NDV-VFD vaccine at optimized conditions showed promising results for up-scaling the process as the RMC was below 3%. However, the virus titer loss was slightly above 1.0 log10 (approximately 1.1 log10). Therefore, the NDV-VFD process requires further optimization at pilot scale to obtain a titer loss of ≤ 1.0 log10. Results from this study provide important guidance for possible industrialization of NDV-VFD vaccine in the future. Key points • The process optimization and scale-up test of thermostable NDV vaccine prepared through VFD is reported for the first time in this study. • The live attenuated NDV-VFD vaccine maintained thermostability for 97 days during long distance transportation in summer without cold chain conditions. • The optimized NDV-VFD vaccine preparations evaluated at pilot-scale maintained acceptable levels of infectivity after preservation at 37℃ for 90 days, which demonstrated the feasibility of the vaccine for industrialization.

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Section: Methodsmentioning

confidence: 99%

Thermostable vacuum foam dried Newcastle disease vaccine: Process optimization and pilot-scale study

Lyu,

Zhao,

Zuo

et al. 2024

Appl Microbiol Biotechnol

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“…Hydrophobic coatings promoted boiling and blow-up phenomena while hydrophilic coatings increased the risk of fogging. In the case of hydrophobic coatings, the addition of surfactant and degasification step prior to nucleation allowed to significantly reduce bubbling for a successful induction of nucleation (Regis et al 2021).…”

Section: Key Elementsmentioning

confidence: 99%

Recent advances and persistent challenges in the design of freeze-drying process for monoclonal antibodies

Hsein

Auffray

Noël

et al. 2022

Pharmaceutical Development and Technology

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Monoclonal antibodies constitute nowadays an important therapeutic class and the number of approved molecules for clinical uses continues to increase, achieving considerable part of the therapeutic market. Yet, the stability in solution of these biopharmaceuticals is often low.That's why freeze-drying has been and remains the method of choice to obtain monoclonal antibodies in the solid state and to improve their stability. The design of freeze-drying process and its optimization are still topical subjects of interest and the pharmaceutical industry is regularly challenged by the requirements of quality, safety and efficiency set by the regulatory authorities. These requirements imply a deep understanding of each step of the freeze-drying process, developing techniques to control the critical parameters and to monitor the quality of the intermediate and the final product. In addition to quality issues, the optimization of the freeze-drying process in order to reduce the cycle length is of great interest since freeze-drying is known to be an energy-expensive and time-consuming process. In this review, we will present the recent literature dealing with the freeze-drying of monoclonal antibodies and focus on the process parameters and strategies used to improve the stability of these molecules and to optimize the FD process.

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“…The findings of the MD simulation study revealed that the hydrophobic coating could stimulate the formation of bubbles and cause a faster liquid film break-up, resulting in a decrease in the onset temperature of explosive boiling [20]. A study conducted by Regis et al (2021) to investigate the effect of hydrophilic and hydrophobic surfaces on vacuum-induced surface freezing (VISF) showed that the hydrophobic surface promotes boiling and blow-up phenomena that could result in the formation of unacceptable defects on the glass surface. Although, the hydrophilic surfaces caused an increased risk of fogging on the inner vial surface [21].…”

Section: Introductionmentioning

confidence: 99%

“…A study conducted by Regis et al (2021) to investigate the effect of hydrophilic and hydrophobic surfaces on vacuum-induced surface freezing (VISF) showed that the hydrophobic surface promotes boiling and blow-up phenomena that could result in the formation of unacceptable defects on the glass surface. Although, the hydrophilic surfaces caused an increased risk of fogging on the inner vial surface [21].…”

Section: Introductionmentioning

confidence: 99%

Effect of Wettability on Vacuum-Driven Bubble Nucleation

et al. 2022

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Nucleation is the formation of a new phase that has the ability to irreversibly and spontaneously grow into a large-sized nucleus within the body of a metastable parent phase. In this experimental work, the effect of wettability on the incipiation of vacuum-driven bubble nucleation, boiling, and the consequent rate of evaporative cooling are studied. One hydrophilic (untreated), and three hydrophobic (chlorinated polydimethylsiloxane, chlorinated fluoroalkylmethylsiloxane and (heptadecafluoro-1,1,2,2-tetrahydrodecyl)triethoxysilane) glass vials of different wettabilities were filled with degassed deionized water and exposed to a controlled vacuum inside a transparent desiccator. The vacuum was increased by 34 mbar abs. (1 inHg rel.) steps with 15-min waiting period to observe bubble nucleation. The average onset pressures for gas/vapor bubble nucleation in CM, CF, and HT vials were 911 ± 30, 911 ± 34, and 925 ± 17 mbar abs., respectively. Bubble nucleation was not observed in hydrophilic vial even at 65 mbar abs. pressure. During the vacuum boiling at 65 mbar abs., the average temperatures of water in hydrophilic, CM, CF, and HT vials reduced from room temperature (~22.5 °C) to 15.2 ± 0.9, 13.1 ± 0.9, 12.9 ± 0.5, and 11.2 ± 0.3 °C, respectively. The results of this study show that the wettability of the container surface has a strong influence on the onset vacuum for vapor/gas bubble nucleation, rate of vacuum boiling, and evaporative cooling. These findings are expected to be useful to develop wettability-based vacuum boiling technologies.

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Surface Treatment of Glass Vials for Lyophilization: Implications for Vacuum-Induced Surface Freezing

Cited by 9 publications

References 41 publications

Thermostable vacuum foam dried Newcastle disease vaccine: Process optimization and pilot-scale study

Thermostable vacuum foam dried Newcastle disease vaccine: Process optimization and pilot-scale study

Recent advances and persistent challenges in the design of freeze-drying process for monoclonal antibodies

Effect of Wettability on Vacuum-Driven Bubble Nucleation

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