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Reportlinker Adds Upstream Processing in Biopharmaceuticals - Increasing Use of Low-Cost Disposable Bioreactors to Drive the Upstream Bioprocessing Market
Date:3/29/2011

ing in Biopharmaceuticals – Guidelines, Regulatory Landscape 88

8.1 Quality by Design (QbD) 88

8.2 Process Analytical Technology (PAT) 90

8.2.1 Importance of PAT 91

8.2.2 Factors Limiting Implementation of PAT 91

8.2.3 A summary of PAT benefits is as follows: 91

8.3 ICH Guidelines 92

8.3.1 Q5A (R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin 92

8.3.2 Q5B: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products 92

8.3.3 Q5C: Quality of Biotechnological Products Stability Testing of Biological Products 93

8.3.4 Q5D: Derivation and Characterizations of Cell Substrates Used for Production of Biotechnological/Biological Products 93

8.3.5 Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process 94

8.4 The US Regulatory Landscape 94

8.4.1 PHS Act 94

8.5 Europe Regulatory Landscape 95

8.5.1 EMEA Guidelines 95

8.5.2 Key Changes in EMEA Guidelines 98

8.5.3 Types of Guidelines within the Biologics Legislative 98

8.6 Japan 98

8.6.1 Health Policy Bureau 98

8.6.2 Office 1 99

8.6.3 Office 2 99

8.6.4 Review and Guidelines 99

9 Upstream Processing in Biopharmaceuticals – Strategic Consolidations 100

9.1 Reasons for Strategic Consolidations in Biologics Manufacturing 100

9.1.1 Uninterrupted Supply to Meet the Demand 100

9.1.2 Overall Cost Reduction 100

9.1.3 Global Expansion to Stay Ahead in Competition 100

9.1.4 High Regulation Requirement 100

9.1.5 Acquiring Technical Expertise 100

9.1.6 Time Pressure and Synergy Innovation 101

9.2 Potential Problems in Strategic Consolidations 101

9.2.1 Incorrect Valuation 101

9.2.2 Capital Problem 101

9.2.3 Compliance Difficulty 101

9.3 Importa
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