Neo Xiong，Co-CEO, Hefei Tianmai Technology Development Co., ltd

Topic: Process Planning and Contemplation of Large-Scale Fermentation on Prokaryotic Expression System

Speaker Bio

Neo Xiong, Co-CEO of Hefei Tianmai Biotechnology Development Co., Ltd., is mainly responsible for overall operation and management of the company, including construction management of product R&D pipeline, production management of biological products, lean production, pharmaceutical quality system management, product registration application (including international registration), project planning and construction, medical devices management of class I and class II, safety and environmental protection, financial budget, cost management, information construction and other related operation management. In his term of office, he has led and passed the registration application, site inspection and GMP certification of 5 biopharmaceutical products. He is also leading API EU and FDA application at present.

Based upon 26 years working experiences of drug production and management including multinational and domestic pharmaceutical companies, he has rich experiences in production and quality management both in chemical and biological products. Meanwhile, he is proficient in overall operation and management of pharmaceutical factory, has a deep understanding of production, quality, process equipment, Research & Development, registration, finance, EHS, and ISO.

Presentation Summary

Prokaryotic expression is one of the main biopharmaceutical expression systems at present, refers to the action of exogenous target gene expressing target protein in specific prokaryotes or prokaryotic cells by gene cloning technology, and through the method of constructing expression vectors and introducing into expression strains. The characteristic is its high efficiency and rapidity. However, there are risks of liquid homogeneity, temperature control and dissolved oxygen control during large-scale fermentation. The presentation will introduce the selection of fermentation tank, basic structure and components of tanks as well as its control theory firstly, and then elaborate the whole process by construction of engineering bacteria, choosing of fermentation medium, seed solution grades, parameters control of fermentation process (temperature, pH, dissolved oxygen, agitation, addition of gases, feeding) its components and control principle, sterile control and etc., providing solutions for difficulties in large-scale fermentation process of prokaryotic expression system.