Zhijie Ding，Vice President and Chief Engineering, Tianjushi Engineering Technology Group Co.,Ltd 

Topic: Design Introduce for Facilities of Biological Products（Mab, Cell Therapy & Gene Therapy）

Speaker Bio

Ms. Ding Zhijie, who has been engaged in the design of the pharmaceutical industry for a long time, is a professor level senior engineer and a registered chemical engineer. In addition, she is a member of National Technical Committee of SAC, expert of Biological Industrialization of STCSM, Manber of the CPAPE Expert Committee, expert of Engineering&Consulting Association, and member of ISPE. Ms. Ding is currently a drafter of the Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration. Ms. Ding serves companies include the largest pharmaceutical design companies and multinational engineering companies in China and serves as the main principal. The projects held by her involve biological products (blood products, vaccines, monoclonal antibody, tissue and recombinant therapeutic protein products, cell therapy, etc.), solid preparations, large-volume injections, diagnostic reagents, medical devices, large animal laboratories, etc. Both small pilot plants and large pharmaceutical projects with an investment of over 1 billion yuan are involved. She is the chief designer of the only cell therapy laboratory in China that has passed the EU examination. 

Presentation Summary

 The factors to be considered in the design of production facilities for Mab, Cell Therapy and Gene Therapy: 

1. The regulations required for the project (GMP).

2. Cross contamination prevention and control of bio-drugs (Mab Drugs, Cell Therapy and Gene Therapy).

3. Influence of production process on the environment and prevention & control of bio-drugs (Mab Drugs, Cell Therapy and Gene Therapy).

4. Influence of production process on the operators and prevention & control of bio-drugs (Mab Drugs, Cell Therapy and Gene Therapy).

5. Design concerns: Biosafety considerations; People flow, logistics, waste flow Settings; Setting of purification air conditioning system; Automatic control and other (including consideration of equipment and facilities).