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On April 19-20, 2018, “USP International Forum on Therapeutic Peptides Quality and Standards 2018” was held in Hangzhou, China, which was organized by the United States Pharmacopoeia (USP).
The forum invited experts from USP, US FDA and National Institutes for Food and Drug Control (NIFDC), chiefs of world-renowned peptide enterprises in China, and thought leaders from biopharmaceutical industry & academic institution, who delivered keynote speeches and brought discussion covering prospects, quality, standards, regulatory, R&D and GMP towards peptides.
This was the first time USP brought such a forum which highly focuses on quality of therapeutic peptide in China. Considering the huge potential market size of therapeutic peptide in China, USP is trying to help local industry on building R&D and manufacturing with strong desire to meet global standards of quality through a series discussion with highly skilled scientific resources. The highly engagement of more than 250 representatives from stakeholders demonstrated a bright future for the peptide and protein-based pharmaceutical industry in China. This forum provided an excellent venue for exchange of ideas and knowledge sharing and has been well recognized by all attendees.
The forum firstly began with a review of USP’s 10 Years in China - Quality and Collaboration, made by Kevin Cao, Senior Director, Strategic Customer Development, USP-China. Then it was divided into sessions focusing on four main topics – 1. Development and opportunities of therapeutic peptides in China; 2. Analytical techniques for peptide characterization and impurity profiling; 3. Compendial standards and program updates on therapeutic peptides; 4. Regulatory considerations for peptide drug products manufacturing and quality.
Speeches delivered by experts from USP
Review of USP’s 10 Years in China - Quality and Collaboration, by Kevin Cao, Senior Director, Strategic Customer Development, USP-China
USP Biologics Overview, by Kevin Carrick, Director, Global Biologics, USP
Therapeutic Peptides USP Program/ Control Strategy for Insulin and Their Analogs, by Michael R. De Felippis, Ph.D., Chair, USP Bio 1 Expert Committee (Peptides & Insulins)
Control Strategies for Synthetic Therapeutic Peptides – USP White Papers and Updates/ Scientific and Regulatory consideration for Generic Peptides in US, by Michael S. Verlander Ph.D., Vice Chair, USP Bio 1 Expert Committee (Peptides & Insulins)
Overview on USP Synthetic and Recombinant Peptides Monographs/ Challenges with Peptide Impurities and USP New Initiative for Developing Peptide Impurities Standards, by Manoj Kumar Metta, Ph.D., Science and Standards Liaison, Global Biologics, USP-India
Speeches delivered by experts from US FDA, NIFDC, and academic institution
Analytical Characterizations and Biological Evaluations of Synthetic and Recombinant Peptides as Complex Drug Products, by Jeff Jiang, Ph.D., Deputy Director, Division of Therapeutic Performance, Office of Research an Standards | Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. FDA
Development and Updates of Recombinant Insulin Analogs Standards, by Chenggang Liang, Ph.D., Deputy Director of Division of Hormone, National Institutes for Food and Drug Control, CFDA
CMC Consideration of Therapeutic Peptide in Pre-Clinical Stage, by Hanmei Xu, Ph.D., Prof., Director, The Engineering Research Center of Peptide Drug Discovery and Development, China Pharmaceutical University
Speeches delivered by heads from leading peptide enterprises in China
Opportunity and Development of Peptide Drugs in China, by Anjin Tao, Ph.D., VP, R&D Division, HYBIO Pharmaceutical Co., Ltd.
Registration Strategy of Synthetic Peptide Drug Considering in Both Domestic and Oversea Market, by, VP of Quality, Chinese Peptide Company
The US FDA GMP Inspection, by Jianjun Jiang, Ph.D., VP, GMP Manufacturing, Hainan Shuangcheng Pharmaceuticals Co., Ltd.
Panel Discussion Q&A, host by Shawn Lee, Ph.D. Chairman, Chinese Peptide Company
Panel Discussion - Q&A
Exchange during the forum, and audiences were deeply absorbed by the topics
Background
Peptides, including synthetic & recombinant peptides, and insulins, has represent fast growing with the rapid development of biotechnology and biopharmaceuticals. Global peptides market is predicted to exceed $25 billion by the end of 2018, that attracted more Chinese companies to seek opportunities in this field. However, due to unique properties and different manufacturing processes of peptides, it still remains lots of challenges.
Being able to manufacture peptides with consistent high quality is a critical priority for manufacturers. USP, as the global leading standard-setting organization for medicines with almost 200 years history, has been committed to the development of biopharmaceutical standards for years, public standards for the quality of peptides is playing a growing role in the supply chain integrity of these drugs.
The forum has provided a platform to present and discuss perspectives on current landscapes and future opportunities of peptides in China, considerations on USP peptides compendial standards development and quality standards for impurities, GMP and regulatory issues, and state-of-the-art technologies for manufacturing and analytical characterizations has also been involved.