Key considerations in CMC research on neoantigen prediction processes
DAI Yi-fei
MA Xiao-juan
LI Huan
XIE Yu-jia
CHEN Ai-ping
Abstract：Neoantigens,also known as tumor-specific antigens,are novel antigenic epitopes generated by unique genetic alterations in tumor cells and,are considered ideal targets for immunotherapy.In recent years,personalized therapies based on neoantigens have made remarkable progress in the field of cancer immunotherapy.However,the accuracy and reliability of neoantigen prediction processes have become the key factors restricting the development of personalized neoantigen immunotherapies.The biological basis of neoantigens and the overview of prediction processes,with a focus on the considerations in chemistry,manufacturing,and control(CMC)research on neoantigen prediction processes are reviewed in this article,and the key points and quality control measures across all stages,from tissue sample acquisition,sequencing data analysis to prediction pipeline development are detailed,aiming to provide a reference for the CMC research and evaluation of personalized neoantigen treatment products,promote the standardization and normalization of neoantigen prediction processes,and facilitate the application and development of neoantigens in precision immunotherapy for cancer.
Keywords：neoantigenprediction processbioinformaticsCMC researchpipeline
Publication Date：2026-03-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 574-578 )