April 19-20, 2018, by United States

The 2018 USP International Forum on peptide drug quality and standards was successfully held in Hangzhou, Zhejiang Province, China.

At the conference, leaders of world-renowned peptide drug R & D enterprises, important experts from us and US regulatory and government agencies such as the US Food and Drug Administration (USFDA) and China food and drug inspection and Research Institute (nifdc), as well as about 20 experts and scholars from other biopharmaceutical industry leaders were invited to attend and deliver keynote speeches. The two-day conference focused on peptide drug R & D, production at home and abroad Quality management, regulatory requirements, development prospects and other important issues were warmly discussed and shared.

In the 21st century, under the background of the rapid rise of global biomedical industry, the field of peptide medicine is also booming at an amazing speed. It is predicted that by the end of 2018, the global peptide drug market will exceed US $25 billion. In the face of huge market opportunities, more and more Chinese manufacturers have incorporated peptide drugs into their main business development strategies. However, the transition from the production of small molecules to the production of peptide drugs with molecular weight between traditional small molecule drugs and biological macromolecules is an important challenge for the production and R & D enterprises. In addition, the diversity of production process, which leads to many difficulties in the quality research and standard formulation of peptide drugs

United States Pharmacopoeia Committee (USP)

As the world's leading pharmaceutical quality standard setting agency with a history of 200 years, it has been committed to developing and developing biopharmaceutical quality standards, including peptide drugs, to help the development of the industry.This conference is the first attempt of USPC in China's biopharmaceutical field. Through the conference, an academic exchange platform was set up to invite experts at home and abroad, such as standard setting institutions, regulatory supervision, peptide R & D and production, to gather with more than 250 industry colleagues to understand the prospects and opportunities of peptide drugs in China, understand GMP production and regulations, and grasp the quality of peptide drugs The development trend of the research technology and the development of the quality standard of polypeptide drugs were inspired. The forum received positive comments and high recognition from the participants, with warm response.

At the beginning of the forum, Mr. Cao Hongxin, senior director of China strategic customer development department of USPC, delivered an opening speech, and reviewed the fruitful results of USPC's cooperation with China's pharmaceutical industry and relevant regulatory agencies on the theme of "quality" in China in the past decade. Subsequently, experts from all walks of life delivered speeches and participated in discussions on the following four topics: 1. Development and opportunities of peptide drugs in China; 2. Analysis, characterization and quality control technology of peptide drugs and related impurities; 3.Pharmacopoeia standard and renewal of polypeptide drugs; 4. Regulatory consideration of production and quality of polypeptide drugs

Keynote speech by experts of USP Committee

Mr. Cao Hongxin, senior director, strategic customer development division, USPC China, reviewed USPC's decade in China: quality and cooperationKevin Carrick, Ph.D., director of global biology department of USP Committee, introduced the overview of USP biological standards

Dr. Michael R. de felippis, chairman of the expert committee of biological 1 (peptide and insulin) of the United States Pharmacopoeia Committee, shared the development and update of the peptide standard of the United States Pharmacopoeia and discussed the quality control strategy of insulin products

Dr. Michael s. Verlander, vice chairman of biological 1 (peptide and insulin) Expert Committee of the United States Pharmacopoeia Committee, introduced the quality control strategy of synthetic peptides - USP white paper and update, and discussed the scientific and regulatory considerations of peptide generic drugs in the United States

Manoj Kumar metta, Ph.D., contact person for science and standards in the global biological Department of USP, describes the general situation of each theory of polypeptide drugs in USP, introduces the challenges in the research of polypeptide drug impurities and the development and update of polypeptide drug impurity standards in USP

US FDA, nifdc and academic experts delivered keynote speeches

Dr. Xiaohui (Jeff) Jiang, Center for drug evaluation and research, US FDA

Deputy director of therapeutic performance department, research and standards / generic office, delivered a keynote speech on "analytical characterization technology and biological evaluation method of synthetic and recombinant polypeptide drugs"

Dr. Liang Chenggang, deputy director of hormone department, Institute of chemical drug control, CFDA, introduced the development and trend of the standard of recombinant insulin drugs

Dr. Xu Hanmei, Professor of China Pharmaceutical University / Director of polypeptide drug Creation Engineering Research Center, member of national pharmacopoeia committee, shares the experience of preclinical pharmaceutical research on polypeptide drugs

Keynote speech by leaders of Chinese peptide EnterprisesDr. Tao Anjin, vice president of research and development of Shenzhen Hanyu Pharmaceutical Co., Ltd., discusses the development and opportunities of peptide drugs in China

Mr. Lu Junbo, vice president of quality of China peptide Biochemical Co., Ltd., shares the domestic and foreign synchronous registration strategies of peptide drugs

Dr. Jiang Jianjun, vice president of peptide API of Hainan Shuangcheng Pharmaceutical Co., Ltd., delivered the keynote speech of "GMP field inspection of FDA in the United States"

Dr. Li Xiang, chairman of China peptide Biochemical Co., Ltd., presided over the theme of "development and opportunities of Chinese peptide drugs"

Many experts participated in the thematic discussion and on-site Q & A

The audience listened to the lively discussion

Shengnuo bio PRODUCT

Best sales manager contact

About Shengnuo

Chengdu Shengnuo Biotechnology Co., Ltd. has "Chengdu polypeptide drug engineering technology research center" in Chengdu, mainly engaged in polypeptide, polypeptide drug and beauty peptide research. Our zero defect has passed the FDA certification, and now it has become the first-class professional peptide drug and product development, technology transfer, technical service and peptide drug industry in the scale production and export of China's parks.