Scale-up and cGMP manufacturing of next-generation vaccine adjuvant saponin/MPLA nanoParticles (SMNP).

ABSTRACT: Saponin/MPLA Nanoparticles (SMNP) is a novel vaccine adjuvant that exhibited excellent safety and potency in a range of preclinical models. Successful scale-up manufacturing under current Good Manufacturing Practices (cGMP) is vital for advancing the clinical development of this promising new adjuvant. Here we report studies transitioning from small-scale formulation to the production of clinical trial material (CTM) in accordance with cGMP. By optimizing the process, a 100-fold scale increase was achieved through closed-system dilution and diafiltration, ensuring both sterility and process efficiency. Analytical characterization confirmed that the SMNP produced under cGMP conditions maintained consistent particle size, morphology, and polydispersity compared to preclinical batches. Hemoly

SUBMITTER: Pallerla S 

PROVIDER: S-EPMC12352820 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature