Therapeutic biologics have become the core engine driving the development of the global pharmaceutical industry, encompassing multiple subfields such as antibodies, recombinant enzymes, immune cells, stem cells, and gene therapies. With strong targeting and marked efficacy, they provide new avenues for treating major diseases and have profoundly altered clinical treatment paradigms. China’s pipeline of biologics in clinical trials ranks among the world leaders, and the industrialization process keeps pacing up. At the same time, however, biologics possess inherent characteristics—complex structures, high heterogeneity, specialized manufacturing processes, and substantial difficulties in quality control—that pose severer challenges to quality research and control than chemical drugs. Quality control of biologics spans the lifecycle from R&D, manufacturing, testing, to post-marketing supervision. It must both resolve existing technical bottlenecks and address the new issues and challenges introduced by novel products. These new issues and challenges range from the standardization dilemmas in activity assessment of recombinant enzyme drugs to the lifecycle quality control difficulties of immune cell therapy products. The quality breakthroughs at each link from the safety risk (such as tumorigenicity) prevention and control of stem cell drugs to the precise detection of multidimensional quality attributes of antibody drugs and to the construction of comprehensive quality control systems for gene therapies play a critical supporting role in the development of the biologics industry.
To summarize and present China’s research achievements in quality control for innovative therapeutic biologics, this journal has established a special column titled “Special Column on the R&D Status and Quality Control of Innovative Therapeutic Biologics” The article “Quality Control Methods in Quality Standards of Antibody Products” focuses on the core quality control items within antibody drug specifications and systematically reviews detection technologies and research progress for key quality attributes such as size heterogeneity, glycan heterogeneity, and biological activity, providing a comprehensive reference for the establishment of antibody drug quality specifications and optimization of quality control methods. The article “Research and Consensus on Activity Evaluation Technologies for Recombinant Enzyme Drugs and Key Enzyme-based Raw and Auxiliary Materials” systematically outlines the core challenges in quality control of recombinant enzyme drugs and critical enzymatic raw and auxiliary materials, and deeply analyzes issues such as lack of standards and incomplete evaluation systems in activity evaluation, offering important theoretical and technical support for the development and regulation of innovative recombinant enzyme drugs. Grounded in the dual attributes of immune cell therapy products as both drugs and living cells, the article “Current Status in Quality Research on Immune Cell-based Therapeutic Products” systematically reviews the classification and research status of these products, examines deficiencies in the current quality control system across three core links—quality research, specification, and analytical methods—and proposes directions for improvement to support the standardized development of the immune cell therapy industry. Focusing on the transition of stem cell therapeutics from basic research to industrial application, the article “Advances in the Research, Development and Quality Control of Stem Cell-based Medicinal Products” reviews the global research status and risk characteristics of stem cell drugs and elaborates on methodological advances in core quality control links such as cell identification, purity analysis, and tumorigenicity testing, clarifying the importance of integrating quality control throughout the entire R&D lifecycle and providing a clear approach to resolving quality control challenges and promoting high-quality industry development of stem cell drugs. The article “Research and Development Status and Quality Control of Gene Therapy Products” provides an overview of the development status of gene therapy drugs and domestic and international regulatory progress, summarizes the characteristics of different product types such as viral vectors and nucleic acid drugs, and systematically describes common and product-specific quality control points from raw materials and process control to release testing, offering a systematic reference for the development and quality evaluation of gene therapy drugs.
Innovation and breakthroughs in quality control technologies for biologics are the core driving force for ensuring medication safety and advancing industrial upgrading. Through this dedicated column, we aim to gather industry expertise, share cutting-edge achievements, promote the exchange and dissemination of quality control technologies of biologics, improve China’s specification and regulatory system for biologics, and drive higher-quality development of China’s biologics industry, and contribute to ensuring the safety and effectiveness of drugs for the people and enhancing the international competitiveness of China’s pharmaceutical industry.