Cancer vaccine characterization: from bench to clinic

Area of Science:

• Vaccinology
• Biotechnology
• Analytical Chemistry

Background:

• Global vaccine development emphasizes safety, efficacy, and affordability.
• High-resolution mass spectrometry (HRMS) is a key technology for vaccine characterization.
• Racotumomab/alumina, a cancer vaccine targeting N-glycolyl-GM3 gangliosides, has undergone clinical trials for melanoma, breast, and lung cancers.

Purpose of the Study:

• To present the physicochemical and biological characterization of the cancer vaccine Racotumomab/alumina.
• To evaluate the impact of production methods on vaccine characteristics.
• To assess the effectiveness of advanced analytical techniques in vaccine development.

Main Methods:

• Racotumomab production scaled from 10 L to 41 L stirred tank fermentation.
• Mass spectrometry (MS) employed for intact molecule, chain masses, amino acid sequencing, N-/C-terminal analysis, glycosylation, and posttranslational modifications.
• Dynamic Light Scattering (DLS) used for size distribution and zeta potential; biological analyses conducted in mice and chickens.

Main Results:

• Observed differences in glycosylation patterns, charge heterogeneity, and structural stability between in vivo-produced and bioreactor-obtained Racotumomab.
• These product variations showed no significant impact on elicited immune responses in murine and avian models.
• Demonstrated the utility of HRMS and DLS in characterizing vaccine products.

Conclusions:

• The characterization approach using advanced technologies like HRMS is effective for vaccine research and development.
• Physicochemical and biological characterization provides in-depth understanding of vaccine products.
• This methodology supports the development of efficient and effective vaccines.