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

nt, Boehringer Ingelheim GmbH, Germany

1. Introduction

2. Stability issues with biologics

3. Liquid versus dry dosage forms

4. Stability testing and quality criteria of drug substance and drug product

5. Conclusions

Chapter 8

Specifications and Drug Substance for Lot Release

Siegfried Schmitt PhD MRSC CChem CSci, Principal Consultant, Parexel Consulting, UK

Ralf Hess MSc PhD, Principal Consultant, Parexel Consulting, Germany

1. EU and US perspectives on setting specifications

2. Setting the specifications (acceptance criteria) and the action limits (critical product quality attributes) for quality control for specific products

3. How specification requirements tighten during development and how to update the package

4. How design space helps with the determination of specifications, especially for generic products outside the originator product specifications

5. Parametric release, i.e. real-time product release

6. Methodologies that need validation

Part Three: Impurity Profiles and Product Variation

Chapter 9

Impurity Profile: How the Process can Impact on the Impurity Profile, and Characterisation of Product and Process Related Impurities

Stefan Zietze MSc PhD, Head of Quality Control,

Marco Riedel PhD, Director of Q A, Qualified Person,

ProBioGen, Berlin, Germany

1. Nature of product- and process-related impurities

2. Characterization of product- and process-related impurities

3. Impact of impurities on product quality

Chapter 10

Impact of the Process on Aggregation, and Technologies for Aggregation Analysis

Professor Nigel Jenkins, Principal Investigator, National Institute of Bioprocessing Research and Training (NIBRT), University College Dublin, Ireland

Dr Ray Tyther, Senior Scientist, NIBRT Laboratory, National Institute for Cellular Biotechnology (NICB), Dublin City
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