Biotechnology

UoG  BDU  MoST AAU  AAUST ARSIUN  DBU  DTU  WU  ESSTI

Ethiopian Scientific and Academic Network
A network of Ethiopian Educators without Borders
Contact: Dr. Abebe Kebede  by email:abkebede@gmail.com

EWB2018: Biotechnology

Host Institutions: Arsi University/ MoST/AAU/AASTU/Debre Birhan University/ Bahir Dar University/ University of Gondar/ Debre Tabor University/Woldia University

III. Overview of process development for recombinant therapeutic proteins: Yinges Yigzaw, PhD Sr. Scientist, Genentech Inc, South San Francisco, California

The discovery of recombinant DNA technology in the 1970s lead to the emergence of genetic engineering as a new industry in biotechnology. Genetic engineering allows the cloning of desired DNA sequence into bacteria or other desirable expression systems and large-scale production of recombinant proteins. In 1982, Genentech successfully cloned and produced the first recombinant human insulin and secured FDA approval for human use. Since then the technology has evolved and enabled to manufacture much more complex therapeutic proteins such as monoclonal antibodies for the treatment of several disease indications in cancer, immunology, cardiovascular and metabolic diseases. These products are referred as biologics or biopharmaceuticals to differentiate from small molecule pharmaceuticals made through traditional chemical synthesis. Advances in bioengineering have benefited millions of patients, created thousands of jobs, and the biologics market is expected to reach ~400 billion by 2025. Before the approval of these products for human use, the process that will be sued to manufacture at large scale needs to be developed and refined through extensive studies at small and pilot scale. These include optimization of the bioreactor condition for optimum protein expression, purification steps for consistent product quality, and formulation condition for reliable protein stability. This presentation will highlight process development focus areas required for the reliable production of a recombinant therapeutic protein.