This paper is reprinted from Chinese Pharmacopoeia Association (cbpia)

On October 18, 2018, reed pharmaceutical exhibition of China biochemical pharmaceutical industry association held a seminar on Key Technologies of protein and peptide drugs in Nanjing International Conference and Exhibition Center. The forum is one of the 30 professional conferences and forums of the 81st China International Pharmaceutical API / intermediate / packaging / Equipment Fair and the 22nd China International Pharmaceutical (industry) exhibition and technology exchange.

It's a great honor to invite Mr. Yang Huaxin, director Fan Huihong and Ren Liping of CFDA, chairman Ji Shengli of Runhui Biotechnology (Weihai) Co., Ltd., director Chen Yuxin of Jiangsu Pulai Pharmaceutical Biotechnology Co., Ltd., chairman Liang Yuanjun of Beijing puluowangkang Pharmaceutical Technology Co., Ltd., and Shanghai Shangyao first biochemical pharmaceutical Co., Ltd Huang Zhenhui, deputy general manager of the company; Xie Yongwei, chairman of Hefei guopeptide Biotechnology Co., Ltd.; Zhu Xiaoguang, chairman of Zhejiang ontolos Biotechnology Co., Ltd.; Huang Yi, Ph.D. of USP standard R & D technology service (Shanghai) Co., Ltd.; MI Pengcheng, R & D department, Shenzhen Hanyu pharmaceutical Co., Ltd.; Dr. Folker steden, Schott Schott; Liu Xiaoguang, antibiotic office, Shanghai Institute of pharmaceutical inspection Director Hao; Secretary General of China protein Pharmaceutical Quality Alliance Shi Jinhai; President Wu Shibin of Jiangsu Wanbang Biochemical Pharmaceutical Group Co., Ltd.; general manager Shen Fei of Nanjing Xinbai Pharmaceutical Co., Ltd.; general manager Zhu Guoji of Xishi Biotechnology Co., Ltd.; Chairman Zhang Junge of Qingdao Shuangyuan Taihe Pharmaceutical Co., Ltd.; General Manager Wang Hua of Jiangsu Chaohua glass products Co., Ltd.; pharmaceutical star (Nanjing) Zhang Haoning, general manager of the company.

On the morning of 18th, Hu Wenyan, executive vice president and Secretary General of China biochemical pharmaceutical industry association, made an opening speech, introducing the main purpose of the conference and making preparations for the establishment of peptide drug branch. In the morning, we are very honored to invite Huang Zhenhui, deputy general manager of Shanghai Shangyao first biochemical pharmaceutical Co., Ltd. as the moderator of the meeting.

Manager Mi Pengcheng introduced the development and opportunity of polypeptide drugs in China from the perspective of global research and development progress of polypeptide drugs, development of polypeptide drugs in China, challenges and opportunities of polypeptide drugs. Polypeptide drugs meet the requirements of relevant policies of the pharmaceutical industry, and the current market acceptance of polypeptide drugs is becoming higher and higher. Domestic polypeptide brands are emerging Jiao, gradually occupy the domestic market and expand the international market.

Chairman Chen Yuxin's report is entitled "research and development and application of anti infective peptide drugs". Chairman Chen mainly introduces the current market situation of peptide drugs and the company's peptide new drug research and development products.

The title of chairman Liang Yuanjun's report is "Discussion on quality control links and requirements for research and development of synthetic peptide drugs". Chairman Liang shared with you the current situation of peptide drug registration, quality control links, quality control requirements and relevant experience of peptide product quality control. Polypeptide synthesis seems to be simple and fast, but it is not easy to say clearly, which requires a solid polypeptide chemical foundation. In the process of quality research, a variety of research methods should be integrated, not limited to the existing standards, and the concept of "quality comes from design" should be fully understood and applied.

Dr. Folker steden, "Application of high quality medical glass in protein and peptide drugs" introduced the influence of borosilicate glass on drugs, and introduced the current advanced technology while sharing experience.

The title of chairman Ji Shengli's report is peptide drugs based on G protein receptor. Chairman Ji Shengli introduced the definition of peptide drugs, SWOT analysis, market prospect of peptide drugs and peptide drugs based on G protein receptor, and shared with you the broad market prospect of drugs based on GPCR target.

After the report, the conference held a round table exchange meeting, and experts and scholars from CFDA, as well as heads of protein peptide drug manufacturing enterprises, and participants had face-to-face exchanges. Shared the industry experience and helped the participants to solve the confusion.

On the afternoon of 18th, representatives of the conference walked into Nanjing meiyaoxing enterprise. In meiyaoxing enterprise Conference Center, we had the honor to invite chairman Ji Shengli to be the host of the afternoon conference. The title of Dr. Huang Yi's report is overview on USP synthetic and recombinant peptides. Dr. Huang made a special report on USP synthetic and recombinant peptides. The main contents include: overview of Pharmacopoeia, legal basis, quality attributes of polypeptide theories and examples of polypeptide theories.

Next, Zhang Haoning, general manager of meiyaoxing (Nanjing) Pharmaceutical Co., Ltd., reported the "FDA GMP inspection sharing". Mr. Zhang shared the experience of meiyaoxing's FDA inspection over the years. He introduced the classification of FDA inspection, precautions in the preparation stage, inspection process and precautions in the inspection summary meeting to the guests on the spot. Then, the guests followed the staff of MedStar to introduce the basic situation of the company, and visited the company's laboratory and production workshop.

The meeting was carried out in the form of theme report, round table exchange, on-site visit and discussion, bringing practical and valuable case sharing to you!

Special thanks to reed Pharma Exhibition Co., Ltd., Jiangsu Chaohua glass products Co., Ltd., meiyaoxing (Nanjing) Pharmaceutical Co., Ltd., Cangzhou Four Star Glass Co., Ltd. and German Schott glass enterprises for their strong support to this conference!

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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.