Neoantigen is a kind of tumor-specific antigen derived from non-synonymous mutations, which plays an important role in the killing of tumor by immune cells, and effective anti-tumor immunity is directly related to tumor neoantigen-specific T cells. Neoantigens are highly immunogenic and specific, not expressed in normal tissues, and bypass the central thymus without immune tolerance, making them ideal targets for anti-tumor immunotherapy. With the development of next-generation sequencing technology and the application of machine learning algorithms, it has become feasible to predict neoantigens, which can detect the differences between tumor cells and normal cells, and determine the best neoantigens to incorporate into tumor vaccines. The individualized nature of neoantigen immunotherapy typically requires 10-30 GMP-grade peptides (selected as neoantigens) to be manufactured for each patient. Peptide neoantigen therapy constitutes a significant paradigm-shift in GMP peptide manufacturing due to the need for multiple peptide sequence targets, rapid peptide synthesis, and small-scale manufacturing (gram-scale).
