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Reportlinker Adds Quality for Biologics

NEW YORK, Nov. 3, 2010 /PRNewswire/ -- announces that a new market research report is available in its catalogue:

Quality for Biologics

Quality for Biologics – New Report

Critical quality attributes, process and change control, product variation, characterisation, and regulatory concerns

Sales of biologics grew by 20% in 2007, far faster than sales of small molecule drugs, which grew by not much more than 5%. The number of biologics being launched is also growing very rapidly, accounting for more than 25% of launches in 2007. But biologics are not like small molecules – they are more complex to develop, test and produce. Any change in production may have a direct effect on both safety and efficacy. Making sure that development, testing and production is done correctly can be expensive, but getting it wrong can be even more expensive and may be disastrous for patients and for the companies involved.

This unique 300 page report can help you to understand the processes involved – knowledge that can save time and money and even make the difference between success and failure.

The report covers all aspects of the subject including

• Critical quality attributes

• Manufacturing process parameters

• Process analytical technology

• Physicochemical analysis,

• Bioassays,

• Formulation and specifications

• Product- and process-related impurities

• Aggregation

• Non-clinical testing

• Clinical development,

• Post-marketing period

• Regulatory authority expectations

• Risk management

• Comparability concerns

Quality for Biologics is edited by Dr Nicole Lyscom and is written by senior industry experts from leading companies and organisations including:



Eli Lilly



Parexel Consulting


Quality for Biologics

Critical quality attributes, process and change control, product variation, characterisation, impurities and regulatory concerns

Table of Contents

Part One: Manufacturing Considerations for Ensuring Product Quality throughout the Life Cycle

Chapter 1

What Controls the Quality of a Biologic?

Alain Bernard PhD, Vice President, Global Process Development & Industrialization, UCB Group, Belgium

Dr Stefanos Grammatikos MSc PhD, Senior Director, Biological Process Development & Industrialization, UCB Group, Belgium

1. Introduction

2. Critical quality attributes: Aspects of a biological that may impact function and safety

3. Impact of the process on the product

4. Setting the specifications

5. Comparability, product lifecycle management and regulatory guidelines

6. Regulatory perspectives

7. Conclusions

Chapter 2

Process Development and Technical Stewardship through the Lifecycle of APIs Manufactured by Cell Culture/Fermentation

Graham McCartney PhD, Technical Lead Biotechnology, Eli Lilly, Ireland

1. Introduction

2. The importance of process understanding and process validation

3. Value of generic platforms for manufacturing processes

4. Viral clearance requirements

Chapter 3

Process Analytical Technology (PAT): Application in Manufacturing of Biologics

Anurag S. Rathore PhD, Research Scientist, Process Development, Amgen Inc., USA

1. Introduction

2. Regulatory guidance

3. Approaches and applications

4. Summary including pitfalls of implementation of PAT in manufacturing

Part Two: Characterization and Analytical Methods

Chapter 4

Introduction: Characterization of the Biologic Product

Thomas Schreitmueller PhD, Head of Analytical R&D and Quality Control Biotech Products, F. Hoffmann-La Roche, Switzerland

1. The historical perspective

2. The current status

3. The perspective

4. Some examples

5. Conclusions

Chapter 5

Technology Selection for Physicochemical Characterisation

Dr John O'Hara, Characterisation Group Leader, Analytical Research and Development, UCB-Celltech, UK

Dr Andy Hooker, Senior Director of Analytical Research and Development, UCB-Celltech, UK

1. Introduction

2. Well characterised biologicals and specified biotechnology products

3. Heterogeneity of biopharmaceutical products and physicochemical testing

4. Evolution in physicochemical characterisation during development

5. Physicochemical characterisation and bioactivity

6. Physicochemical lot release testing

7. Case studies

Chapter 6

Bioassays for Lot Release and Comparability

C. Jane Robinson PhD Principal Scientist, Biotherapeutics, National Institute for Biological Standards and Control, UK

1. Introduction

2. Biological activity, potency, functional assays

3. Selection of appropriate bioassay systems

4. Types of functional bioassay system

5. Binding assays

6. Immunoassays

7. Bioassays and unwanted immunogenicity

8. Assay variability, reference standards and relative potency

9. Assay Design

10. Assay precision

11. Surrogate potency assays

Chapter 7

Impact of Formulation Design on Stability and Quality

Patrick Garidel PhD

Stefan Bassarab PhD

Department of Process Science, Formulation Development, 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 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

Wassim Nashabeh Ph.D., Director, CMC Regulatory Affairs,

Ron Taticek Ph.D., Director, CMC Regulatory Affairs,

Reed J. Harris, BSc, Senior Director, Protein Analytical Chemistry

Genentech, Inc., USA.

1. Introduction

2. Definitions and scope

3. General principles

Supplement: A QbD Approach to Biopharmaceutical Glycosylation:

Dr Daryl Fernandes, Chief Executive, Ludger Ltd

Part 1: Importance of glycosylation to developers and manufacturers of glycoprotein therapeutics

1. Introduction

2. Why measure quality of biopharmaceutical glycosylation?

3. Glycosylation and risk in biopharmaceutical production

4. Steps for setting up a glycosylation quality system

Part 2 – Glycoprofiles and Glycoprofiling

1. Introduction

2. Monosaccharide profiling

3. Oligosaccharide profiling

4. Glycosylation site profile

5. Glycoform profile

6. Glycoprofiling throughout the drug life cycle

7. Conclusions

About the Contributors

To order this report:

Biopharmaceutical Industry: Quality for Biologics

Biopharmaceutical Business News

More  Market Research Report

Check our  Company Profile, SWOT and Revenue Analysis!

Nicolas Bombourg



US: (805)652-2626

Intl: +1 805-652-2626

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