Elaborate in detail on a typical sequence of proce

Elaborate in detail on a typical sequence of process validation activities for a biopharmaceutical product, and suggest a process validation workflow.

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Process Validation of a Biopharmaceutical Product

INSTRUCTIONS:

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.

CONTENT:

Process validation of a biopharmaceutical product Student: Professor: Course title: Date: Table of Contents  TOC o "1-3" h z u  HYPERLINK l "_Toc418159059" Process validation of a biopharmaceutical product  PAGEREF _Toc418159059 h 4  HYPERLINK l "_Toc418159063" 1.0 Mini-project Descriptor Part 1: Sequence of process validation activities  PAGEREF _Toc418159063 h 4  HYPERLINK l "_Toc418159064" 1.1 The necessary process validation workflow  PAGEREF _Toc418159064 h 8  HYPERLINK l "_Toc418159065" 2.0 Mini-project Descriptor Part 2: Process Validation prerequisites  PAGEREF _Toc418159065 h 9  HYPERLINK l "_Toc418159066" 2.1 Planning  PAGEREF _Toc418159066 h 10  HYPERLINK l "_Toc418159067" 2.2 Process Development  PAGEREF _Toc418159067 h 10  HYPERLINK l "_Toc418159068" 2.2.1 The activities that lead up to the formal process validation  PAGEREF _Toc418159068 h 10  HYPERLINK l "_Toc418159069" 2.2.2 Prerequisite for raw materials  PAGEREF _Toc418159069 h 11  HYPERLINK l "_Toc418159070" 2.2.3 Description of the process  PAGEREF _Toc418159070 h 11  HYPERLINK l "_Toc418159071" 2.2 Equipment and Facilities  PAGEREF _Toc418159071 h 11  HYPERLINK l "_Toc418159072" 2.3 Prerequisites regarding training  PAGEREF _Toc418159072 h 11  HYPERLINK l "_Toc418159073" 3.0 Mini-project Descriptor Part 3: Characterization of the cell line  PAGEREF _Toc418159073 h 1...

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