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Reportlinker Adds Quality for Biologics
Date:11/3/2010

University, Ireland

Dr Lisa Murphy, Senior Scientist, NIBRT Laboratory, National Institute for Cellular Biotechnology (NICB), Dublin City University, Ireland

1. Introduction

2. Interventions in the protein secretory pathway

3. Disulphide bond formation

4. Chaperones

5. Multiple gene activators

6. Environmental conditions

7. Analytical methods to detect misfolding and aggregation

8. Conclusions

Chapter 11

Importance of Non-Clinical Testing

Nadja Prang-Richard PhD MBA, Program Director for Monoclonal Antibodies, LFB, France and Co-Founder & Scientific Advisory Board Member, Lophius, Biosciences, Germany

1. Introduction

2. Regulatory aspects

3. In vitro systems

4. In vivo systems

5. Pharmacokinetics

6. Toxicology studies

7. Non-clinical testing in (BIO)pharmaceutical development

Part Four: Regulatory Considerations Regarding Product Quality

Chapter 12

Current Safety and Efficacy Concerns of the Regulatory Authorities

Frits Lekkerkerker MD, Former CHMP Member and Chairman, Medicines Evaluation Board, Netherlands, Member Advisory Board, NDA Regulatory Science Ltd

1. History

2. New regulatory guidance

3. Expectations of the regulatory authorities

4. Where the industry tends to go wrong

5. Will biologicals become harder to regulate?

Chapter 13

Requirements for an Effective CMC Regulatory Compliance Strategy

Steffen Gross, PhD, Laboratory Head and Scientific Assessor (Quality, Pre-clinic Section Monoclonal and Polyclonal Antibodies, Paul-Ehrlich-Institute, Germany

1. Introduction

2. CMC requirements for dossier filing

3. Development of a product - interaction with regulatory authorities

Chapter 14

Regulatory Considerations in Performing Comparability Studies for Biotechnology Products: An Industry Perspective

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