Process Validation of a Biopharmaceutical Product

Process validation of a biopharmaceutical product
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Table of Contents
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Process validation of a biopharmaceutical product  PAGEREF _Toc418159059 \h
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1.0 Mini-project Descriptor Part 1: Sequence of process validation activities  PAGEREF _Toc418159063 \h
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1.1 The necessary process validation workflow  PAGEREF _Toc418159064 \h
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2.0 Mini-project Descriptor Part 2: Process Validation prerequisites  PAGEREF _Toc418159065 \h
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2.1 Planning  PAGEREF _Toc418159066 \h
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2.2 Process Development  PAGEREF _Toc418159067 \h
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2.2.1 The activities that lead up to the formal process validation  PAGEREF _Toc418159068 \h
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2.2.2 Prerequisite for raw materials  PAGEREF _Toc418159069 \h
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2.2.3 Description of the process  PAGEREF _Toc418159070 \h
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2.2 Equipment and Facilities  PAGEREF _Toc418159071 \h
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2.3 Prerequisites regarding training  PAGEREF _Toc418159072 \h
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3.0 Mini-project Descriptor Part 3: Characterization of the cell line  PAGEREF _Toc418159073 \h
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4.0 Mini-project Descriptor Part 4: Study protocols in process validation program  PAGEREF _Toc418159074 \h
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4.1 Viral Clearance  PAGEREF _Toc418159075 \h
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4.2 Impurity Clearance  PAGEREF _Toc418159076 \h
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4.3 Process Consistency (conformance lot validation)  PAGEREF _Toc418159077 \h
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4.4 Process Intermediate Stability  PAGEREF _Toc418159078 \h
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4.5 Process Solution Stability  PAGEREF _Toc418159079 \h
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4.6 Drug Substance fill, freeze, thaw, and storage  PAGEREF _Toc418159080 \h
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4.7 Mixing studies (process and process solutions)  PAGEREF _Toc418159081 \h
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4.8 Chromatography resin and reusable filter membrane lifetime validation  PAGEREF _Toc418159082 \h
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5.0 Mini-project Descriptor Part 5: Viral contamination of medicinal products  PAGEREF _Toc418159083 \h
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5.1 Preventative measures  PAGEREF _Toc418159084 \h
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5.1.1 Screening of viral contamination in the Master Cell Bank  PAGEREF _Toc418159085 \h
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5.1.2 Working Cell Bank  PAGEREF _Toc418159086 \h
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5.1.3 Cells at the limit of in vitro cell age  PAGEREF _Toc418159087 \h
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5.1.4 Tests for retroviruses  PAGEREF _Toc418159088 \h
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