ABSTRACT
The manufacturing of biopharmaceuticals bears unique differences from the respective manufacturing of low molecular weight medicines. Low molecular weight medicines are usually organic compounds. Their manufacturing is achieved with the help of organic chemistry, i.e., the successive steps of adding chemical atoms and side chains to a molecular frame. Modern biotechnology techniques have allowed the safe, effective, efficient, and fast production of large quantities of high molecular weight biologics under the strictest manufacturing practices. The need for the development of newer and improved biomanufacturing expression systems originated from the following necessities: increased yield, production stability, simplicity, batch contamination improvement, higher protein complexity, more human-like characteristics, increased production volumes, reduced costs, increased production portability, and increased production scalability. As in the case of transgenic plants, genetically altering the genome of animals in order to produce a new protein is a novel biomanufacturing platform that can address the following production issues.
