聚焦生物制药稳定性研究,助力我国生物制药产业的高质量发展

Focusing on biopharmaceutical stability study and promoting the high-quality development of the biopharmaceutical industry in China

关键词:  生物制药  稳定性  抗体药物  前沿疗法  质量研究

Key words:  Biopharmaceuticals  Stability  Antibody-based therapeutics  Advanced Therapy  Quality study

摘要:

近年来,以重组蛋白、抗体药物、疫苗、核酸、细胞和基因治疗等为代表的生物制药逐渐成为当前世界医药研发的热点和发展方向,但这些生物制药易发生降解,影响药物的安全性和有效性。生物制药稳定性问题的解决需要多学科和领域的紧密协作,包括基础机理研究、工艺开发、制剂开发、生产和质量分析等。为了国内外研究人员能够更好的了解生物制药稳定性研究发展趋势和新技术热点,本期推出“生物制药稳定性研究”专栏,邀请来自企业界、高校、监管部门等生物制药稳定性领域的知名专家投稿,刊出一批具有创新性和应用性的论文,内容丰富全面,为生物制药的长足发展提供新思路和新动力,共同推动我国生物制药产业的高质量发展。

Abstract:

ABSTRACT: Over the past decades, biopharmaceuticals, including recombinant proteins, antibody-based therapeutics, vaccines, nucleic acids, and cellular and gene therapies, have become the focus and future directions of the pharmaceutical industry worldwide. However, biopharmaceuticals are usually of only marginal stability and are prone to chemical and physical degradations, affecting their safety and efficacy. The solution of biopharmaceutical stability issues requires multidisciplinary collaborations among different fields, including mechanism study, process development, formulation development, manufacturing, and quality analysis. To facilitate the understanding of the current status, future directions, and novel techniques for the biopharmaceutical stability research, the special “Biopharmaceutical Stability Research” column is established to invite well-known experts from industry, academia, and regulatory authorities to submit innovative and application-oriented articles in the biopharmaceutical stability areas. The articles published in this column cover major areas related to the biopharmaceutical stability research and give new ideas and strength for the biopharmaceutical development, promoting the high-quality development of the biopharmaceutical industry in China.