Aves Kara-Lee, Janitzek Christoph M, Fougeroux Cyrielle E, Theander Thor G, Sander Adam F
Department of Immunology and Microbiology, University of Copenhagen, 2200 Copenhagen, Denmark.
AdaptVac, Ole Maaløes Vej 3, 2200 Copenhagen, Denmark.
Pharmaceutics. 2022 Jun 18;14(6):1301. doi: 10.3390/pharmaceutics14061301.
The requirement of an undisrupted cold chain during vaccine distribution is a major economic and logistical challenge limiting global vaccine access. Modular, nanoparticle-based platforms are expected to play an increasingly important role in the development of the next-generation vaccines. However, as with most vaccines, they are dependent on the cold chain in order to maintain stability and efficacy. Therefore, there is a pressing need to develop thermostable formulations that can be stored at ambient temperature for extended periods without the loss of vaccine efficacy. Here, we investigate the compatibility of the Tag/Catcher AP205 capsid virus-like particle (cVLP) vaccine platform with the freeze-drying process. Tag/Catcher cVLPs can be freeze-dried under diverse buffer and excipient conditions while maintaining their original biophysical properties. Additionally, we show that for two model cVLP vaccines, including a clinically tested SARS-CoV-2 vaccine, freeze-drying results in a product that once reconstituted retains the structural integrity and immunogenicity of the original material, even following storage under accelerated heat stress conditions. Furthermore, the freeze-dried SARS-CoV-2 cVLP vaccine is stable for up to 6 months at ambient temperature. Our study offers a potential solution to overcome the current limitations associated with the cold chain and may help minimize the need for low-temperature storage.
疫苗分发过程中对冷链不间断的要求是限制全球疫苗可及性的一项重大经济和后勤挑战。基于纳米颗粒的模块化平台有望在下一代疫苗的开发中发挥越来越重要的作用。然而，与大多数疫苗一样，它们依赖冷链来维持稳定性和效力。因此，迫切需要开发能够在环境温度下长期储存而不损失疫苗效力的热稳定制剂。在此，我们研究了Tag/Catcher AP205衣壳病毒样颗粒（cVLP）疫苗平台与冻干过程的兼容性。Tag/Catcher cVLPs可以在多种缓冲液和赋形剂条件下进行冻干，同时保持其原始生物物理性质。此外，我们表明，对于两种模型cVLP疫苗，包括一种经过临床测试的SARS-CoV-2疫苗，冻干后的产品一旦复溶，即使在加速热应激条件下储存后，仍保留原始材料的结构完整性和免疫原性。此外，冻干的SARS-CoV-2 cVLP疫苗在环境温度下可稳定保存长达6个月。我们的研究为克服当前与冷链相关的限制提供了一种潜在解决方案，并可能有助于尽量减少低温储存的需求。
