The structure : with the results 



1-Mini-project Descriptor Part-1 (10%)

Elaborate in detail on a typical sequence of process validation activities for a

biopharmaceutical product, and suggest a process validation workflow.



2- Mini-project Descriptor Part-2 (10%)

What are the typical prerequisites to a process validation study?



3- Mini-project Descriptor Part-3 (15%)

Explain why complete characterization of the cell line is an important process validation

study, going all the way back to the origin of the cell line. Mini-project Descriptor



4- Part-4 (20%)

Explain why a process validation program should include study protocols on the following

items:

a. Viral clearance

b. Impurity clearance (Nucleic acid, Immunogenic, Pyrogenic, etc.)

c. Process consistency (conformance lot validation)

d. Process intermediate stability

e. Process solution stability

f. Drug substance fill, freeze, thaw, and storage

g. Mixing studies (product and process solutions)

h. Chromatography resin and reusable filter membrane lifetime validation



5- Mini-project Descriptor (15%)

Why are biopharmaceutical manufactures so concerned about viral contamination of their

finished medicinal products, and what preventative measures can they put in place to

mitigate against this?



6- Mini-project Descriptor (30%)

Based on observation from your NIBRT workshops, summarize, categorize and discuss the

operational and performance parameters associated with the upstream and downstream

drug-substance processes. Report Length: ( in this part I will give you some information about it to go through it ) 







Your report should be at least 6000-words. Please include a table-of- contents and section headings. Be as innovative in your thinking as possible. If possible



sketch out your own relationship diagram(s) that models and reflect your thinking and

conclusion.