Process Validation of a Biopharmaceutical Product
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.
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 12
HYPERLINK \l "_Toc418159074" 4.0 Mini-project Descriptor Part 4: Study protocols in process validation program PAGEREF _Toc418159074 \h 12
HYPERLINK \l "_Toc418159075" 4.1 Viral Clearance PAGEREF _Toc418159075 \h 12
HYPERLINK \l "_Toc418159076" 4.2 Impurity Clearance PAGEREF _Toc418159076 \h 13
HYPERLINK \l "_Toc418159077" 4.3 Process Consistency (conformance lot validation) PAGEREF _Toc418159077 \h 14
HYPERLINK \l "_Toc418159078" 4.4 Process Intermediate Stability PAGEREF _Toc418159078 \h 15
HYPERLINK \l "_Toc418159079" 4.5 Process Solution Stability PAGEREF _Toc418159079 \h 15
HYPERLINK \l "_Toc418159080" 4.6 Drug Substance fill, freeze, thaw, and storage PAGEREF _Toc418159080 \h 16
HYPERLINK \l "_Toc418159081" 4.7 Mixing studies (process and process solutions) PAGEREF _Toc418159081 \h 17
HYPERLINK \l "_Toc418159082" 4.8 Chromatography resin and reusable filter membrane lifetime validation PAGEREF _Toc418159082 \h 18
HYPERLINK \l "_Toc418159083" 5.0 Mini-project Descriptor Part 5: Viral contamination of medicinal products PAGEREF _Toc418159083 \h 18
HYPERLINK \l "_Toc418159084" 5.1 Preventative measures PAGEREF _Toc418159084 \h 19
HYPERLINK \l "_Toc418159085" 5.1.1 Screening of viral contamination in the Master Cell Bank PAGEREF _Toc418159085 \h 20
HYPERLINK \l "_Toc418159086" 5.1.2 Working Cell Bank PAGEREF _Toc418159086 \h 20
HYPERLINK \l "_Toc418159087" 5.1.3 Cells at the limit of in vitro cell age PAGEREF _Toc418159087 \h 21
HYPERLINK \l "_Toc418159088" 5.1.4 Tests for retroviruses PAGEREF _Toc418159088 \h 21
HYPERLINK \l "_Toc4...
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