Question: Part I: 1. Explain the process of the Ion Exchange Chromatography as a purification method for protein in the pharmaceutical industry. Use simple terms to explain and must have APA refences. 1 full page double spaced (Not including refences, they must be apart)

2. Why would it be important to collect data for that process on the pharmaceutical industry? Couple of sentences with APA references.

3. Provide an operational definition of quality of this process

4. Propose how to empirically collect the process output data (in this case the chromatography column will attract my main biomolecule and will repel the impurities; after it will be wash with a buffer to remove the biomolecule from the chromatography resin. The data collected will be the final concentration after the buffer wash; data will be read by an inline HPLC).

Part II: 1. Using the process (See part I), describe the area of variation. Then, suggest methods to reduce variability in the process. Finally, explain the biggest obstacle(s) to overcome in the implementation of this new method. Use APA refences.