Highly Efficient Protein Manufacturing Process

Downstream process only 1 chromatography column Isolation /recovery homogenization /centrifugation Solubilization /refold 

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The great demand for high-quality therapeutic proteins requires efficient manufacturing processes, both upstream and downstream. 

In Chapters 13 and 14 of this book the applications of conventional chemical catalysts were described. The use of enzymes or whole cells as catalysts for chemical transformations is well known. They can bring about various reactions at ambient temperature and pressure and afford high reaction velocities. In fact, enzymatic reaction sequences may be designed to give the ideal efficiency embodied in the second law of thermodynamics. Thus, hundreds of compounds that are very difficult to prepare by purely chemical methods may be obtained quite readily and economically with the help of enzymes. Until recently, most laboratory investigations and manufacturing processes employed soluble enzymes in dilute aqueous solutions. Before use, the required enzyme must be obtained from biological sources as a concentrated extract. It is not uncommon for a particular type of cell to contain many proteins in addition to the one desired. Therefore, the purification and concentration of enzymes in preparation for use is a very cumbersome process. When used in solution, enzyme catalysts are invariably lost after each batch operation. The use of immobilized enzymes and whole cells has been proposed as a means that could eliminate such losses and preserve hard won stocks of specialized enzymes. 

The adult human body, on an ordinary daily diet containing 80-100 gm of protein, manufactures and excretes upwards of 20 gm. of urea, per diem, which represents more than 11 gm. of ammonia. Consequently, ureagenesis is a process of the greatest importance. The mechanism is highly efficient, and there are no pathological records of its complete failure in any known disease. 

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