Reference no: EM133201097

Questions

1. What are the key trends in the world market for enzymes - how has the enzyme market grown over the past decade? How has the worldwide production of enzymes changed? Who are some of the current major players and what are their major products / markets? What need applications are emerging for the industrial use of enzymes?

2. What are some important considerations in the production of bulk enzymes for industrial food applications? With some specific examples, compare and contrast production of these enzymes with the production of therapeutic enzymes. What are the best sources for these enzymes? How does a company balance safety/purity and production cost? How can large-scale production be optimized and production of the enzymes maximized?

3. What are some emerging techniques for improving enzyme production? Describe how genetic engineering can be used to change the specificity, efficiency and operating characteristics of enzymes. Discuss some cost effective solutions for recovery, isolation and purification of enzymes. If a company was interested in producing pepsin from fish viscera as a digestible therapy, what kind of downstream processing would you recommend?

4. What advantages are there to immobilizing an enzyme? Are there any disadvantages? Describe how an enzyme works as a catalyst, how to determine what rate limiting steps and how immobilization affects enzyme performance. How can the stability, selectivity and activity of immobilized enzymes be controlled? What are some of the new technologies that are changing enzyme immobilization?

5. What are important considerations in the production of recombinant therapeutic proteins? How would these differ if the proteins were being produced in Europe for use in Europe? Describe the process for bioproduction of insulin and how it has evolved over the past 35 years.

6. If a company wanted to mass produce a humanized monoclonal antibody against epithelial cell adhesion molecule (EpCAM) how would it do so? Describe all the steps involved, starting with how an antibody against a protein is initially created, then how it is engineered and optimized and how it is manufactured on a large scale.

7. What are the desirable characteristics of a gene vector? Describe the components of the glutamine synthetase gene expression system. What is the advantage of using this approach for antibody production? How does Lonza select a cell line selected for production? How is the process optimized and how much can it be improved by? How does upstream optimization affect downstream choices in antibody production?

8. Describe the downstream steps for isolation, purification and concentration of antibodies. How are contaminants such as viral particles removed? How is the trade-off between yield, purity and cost for a therapeutic antibody different to that for production of an antibody for in vitro immunohistochemistry.