Pallerla, S., et al. Scale-up and cGMP manufacturing of next-generation vaccine adjuvant Saponin/MPLA NanoParticles (SMNP). J Pharm Sci, 2025 Jul 19, 114(9):103913.

Pallerla, S., et al. Scale-up and cGMP manufacturing of next-generation vaccine adjuvant Saponin/MPLA NanoParticles (SMNP). J Pharm Sci, 2025 Jul 19, 114(9):103913. PMID: 40692104

• This study reports the successful scale-up and cGMP manufacturing of saponin/MPLA nanoParticles (SMNP), a novel nanoparticle vaccine adjuvant combining saponin and MPLA, into a clinical-grade product consistent in quality, morphology, and stability with smaller preclinical batches. The process optimizes formulation parameters, such as buffer pH during detergent removal, enabling reproducible large-scale production with minimized manual handling, thereby enhancing scalability and regulatory compliance. 
• Stability studies demonstrate that SMNP maintains colloidal integrity and structural morphology over 24 months when stored refrigerated at 5 ± 3 °C, although physical stability diminishes at higher or frozen temperatures. These findings establish a robust, scalable manufacturing platform ready for clinical application, addressing key challenges of physicochemical sensitivity and process reproducibility in producing complex nanostructured adjuvants.
• This work is important because it advances the production of a promising vaccine adjuvant, SMNP, from research-scale to clinical-grade manufacturing, addressing critical challenges in scalability, regulatory compliance, and quality control. By establishing a reproducible, cGMP-compliant process, it enables the broader deployment of potent adjuvants necessary for developing effective vaccines against emerging infectious diseases, pandemics, and in immuno-oncology. Ensuring consistent quality, stability, and safety of complex nanostructured adjuvants at scale is essential for their successful clinical translation and eventual widespread use, ultimately enhancing global vaccine capabilities and public health preparedness.

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