Professor Rao Chunming to Speak at CPHI China 2025 Side Event on Quality Control of Cell and Gene Therapy Products
On the occasion of the 23rd CPHI China (CPHI China 2025), VCBeat has specially organized a Symposium on Quality Control for Cell and Gene Therapy Products. On June 24, renowned scholars, clinical experts, corporate executives, and regulatory authorities will convene at the Shanghai New International Expo Centre to engage in in-depth discussions on recent advances in cell and gene therapy technologies, key challenges in drug development, and innovative applications of life science instruments.
We are honored to have invitedProfessor Rao Chunming, Former Director of the Recombinant Drug Division at the National Institutes for Food and Drug Control (NIFDC) Institute for Biological Products Control, and Senior Researcher (Grade II), bringing us"Quality Control Research and Related Regulatory Requirements for Biotechnological Drugs"Topic Sharing.
Graduated from Xiamen University in 1983 and was assigned to work at the National Institute for the Control of Pharmaceutical and Biological Products (NICPBP). Since 1993, has successively served as Deputy Director and Director of the Biochemistry Laboratory, Director of the Recombinant Technology Products Laboratory, and Director of the Recombinant Drugs Division at the Institute for Biological Products Control, China National Institutes for Food and Drug Control (NIFDC), holding the title of Senior Researcher (Grade II). In February 2021, appointed as Deputy Secretary-General of the China Biochemical Pharmaceutical Industry Association. In February 2023, appointed as Chief Scientist at Beijing Joinn Laboratories Drug Control & Research Co., Ltd. Concurrently serves as a member of the 8th–11th Chinese Pharmacopoeia Commission, Executive Member of the 11th Chinese Pharmacopoeia Commission, and Chairperson of the Professional Committee on General Chapters for Biological Products.
Primarily engaged in quality research and control of biotechnological products. Since 1986, has participated in and undertaken national projects during the “7th Five-Year Plan” through the “13th Five-Year Plan” periods. Established the quality control technology platform for recombinant therapeutic products at the National Institutes for Food and Drug Control (NIFDC) from the ground up. Some research achievements have been incorporated as national standards into the Chinese Pharmacopoeia. Recipient of one Second-Class Prize for National Scientific and Technological Progress, five provincial/ministerial-level Scientific and Technological Progress Awards, and the State Council Special Government Allowance, among other honors. Has published 276 academic papers, co-authored 13 books, and been granted 13 patents.
Biopharmaceuticals encompass a wide variety of products, including recombinant protein therapeutics such as cytokines, hormones, enzymes, antibodies, fusion proteins, and therapeutic vaccines, as well as gene therapy drugs with diverse vectors and various types of cell therapy drugs. Due to their complex structures and functions, these products demand stringent quality control requirements. Professor Rao Chunming will primarily discuss the scientific basis for establishing quality standards for biopharmaceuticals, along with the quality control standards, analytical methods, and reference standards developed for recombinant therapeutics.
Relevant Regulatory Requirements
Research and Establishment of Quality Standards and Testing Methods
Preparation and Calibration/Identification of Reference Materials
Establishment and Testing of Cell Banks and Microbial/Viral Seed Lots
Viral Safety Control
Event Time:June 24, 13:30–17:00 (Tuesday, afternoon of Day 1 of CPHI)
Event Venue:Conference Room B51, Hall W11, Shanghai New International Expo Centre
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