Biomanufacturing Strategies: Market Drivers, Build-vs-buy Decisions And Opportunities In Contract Relationship Management

Published by: Business Insights

Published: Sep. 1, 2007 - 182 Pages

Table of Contents

Biomanufacturing Strategies

Executive Summary

Introduction

Manufacturing of biologics

The contract biomanufacturing market

Outsourcing biomanufacturing

Contract Manufacturing Organizations

Trends in biomanufacturing

Chapter 1 Introduction

Summary

Introduction

The state of the biomanufacturing industry

Biotech drugs as blockbusters

The contract biomanufacturing sector

Overview of the biomanufacturing process

Microbial Fermentation

Mammalian cell culture

Transgenics/plant systems

Conclusions and key findings

Chapter 2 Manufacturing of biologics

Summary

Introduction

The biopharmaceutical process

The Upstream Process

Cell banking and seed culture

Production

Harvest and concentration

The Downstream process

Purification of biopharmaceuticals

Formulation

The importance of process integration

Expression systems for therapeutic protein production

Therapeutic protein production in microbes

Mammalian cell culture

Emerging production systems

Pichia and filamentous fungi

Transgenic protein production systems

Transgenic animals

Chapter 3 The contract biomanufacturing market

Summary

Introduction

Overview of the global contract biomanufacturing market

The contract biomanufacturing market as part of the global pharmaceutical

market

Total market size forecasts

Global biomanufacturing capacity forecasts

Current market drivers

Expansion of the market for biopharmaceutical products

Facility cost

Manufacturing expertise and innovation

Risk reduction and time to market

Growing regulatory burden and shortage of personnel

The emergence of biosimilars

Current market restraints

In-house production and overcapacity

Loss of manufacturing control

Technology transfer and intellectual property (IP) concerns

Increased competition among CMOs

Longer clinical and approval times for biopharmaceuticals

Chapter 4 Outsourcing biomanufacturing

Summary

Introduction

The build vs. buy decision

What is the strategy for the future of the biotech company?

The outsourcing option and availability of external manufacturing capacity

Capital requirements and operating cost structure

Risk management

Managing contract biomanufacturing

Key selection criteria

The CMO Selection Process

The sponsor - CMO relationship

Starting the relationship

Technology transfer

Weekly and daily interaction

The reality of costs

When things go wrong

Conclusions

Chapter 5 Contract Manufacturing

Organizations

Summary

Introduction

Major players

Lonza Group

Mammalian cell culture

Microbial fermentation

Biopharma services

Boehringer Ingelheim

Boehringer Ingelheim’s expansion strategy

Boehringer Ingelheim’s contract services and proprietary technology

platforms

DSM Pharmaceutical Products

DSM Pharmaceuticals’ contract services

Celltrion

Bioreactor facilities

Celltrion expansion

Diosynth

Diosynth’s contract manufacturing deals

Medium-sized and small players

Baxter BioPharma Solutions

Baxter’s contract services

Cobra Biomanufacturing plc

Cobra’s contract services and proprietary technology platforms

Xcellerex

PDMaxTM Process Development Platform

FlexFactoryTM Manufacturing

XDRTM - Xcellerex Disposable Reactor

Xcellerex’s funding and manufacturing deals

Avecia

The pAVEwayTM production platform

Avecia’s manufacturing deals

Chapter 6 Trends in Biomanufacturing

Summary

Introduction

Bioprocess development strategies

Production line selection and engineering

Cell culture media

Disposable technology

Drivers for disposable technologies

Single use and disposable bioreactor systems

Disposable systems in downstream processes

Improving productivity in downstream processing

Harmonizing upstream and downstream capacities

Transgenic production systems

Cost considerations

The perception of transgenics

Process analytical technology (PAT)

Regulation shifts from product to process

Defining PAT and its meaning to a biomanufacturing company

PAT in biomanufacturing

Process control tools used for PAT

Globalization / Offshoring to Asia

Shared capacity - the future of biomanufacturing?

Conclusions - The future of contract biomanufacturing

Chapter 7 Appendix

Bibliography

Index

List of Figures

Figure 2.1: Schematic flow diagram of a typical biopharmaceutical process

Figure 2.2: Expression system decision framework

Figure 3.3: CMO market growth as part of the global pharmaceutical market, 2001 and 2007

Figure 3.4: Size of the contract biomanufacturing market, 2000-2008e

Figure 3.5: Ratio of biopharma companies producing 100% in-house (mammalian cell culture), 2003-2011e

Figure 3.6: Biopharma companies planning to outsource at least part of their production, 2006 and 2011e

Figure 3.7: Mammalian Cell Culture Bioreactor Capacity, 2003 -2009e

Figure 3.8: Microbial Fermenter Volume Capacity, 2003 -2009e

Figure 3.9: Number of biotech drugs and global biotech industry revenues, 1990-2005

Figure 3.10: Antibody-derived therapies in biotechnology pipeline, 2007

Figure 3.11: Cash reserves of biotech companies, 2005

Figure 3.12: Sensitivity of fermentation volume required depending on yield and market demand

Figure 3.13: Factors creating capacity constraints by 2008

Figure 3.14: CMO Mammalian Cell Culture Production Capacity Increase 2003 -2006

Figure 3.15: Mean clinical and approval time-frames for biopharmaceuticals approved, 1996-2000 vs. 2001-2005

Figure 4.16: Framework for the build vs. buy decision

Figure 4.17: Mammalian Cell Culture Capacity Distribution for CMOs, 2004 and 2008(estimate)

Figure 4.18: Distribution of biomanufacturing capacity

Figure 4.19: Proposed timeline for commercial contract biomanufacturing

Figure 4.20: Financial ‘Build or Buy’ decision tree

Figure 4.21: Transition (success) probabilities for biopharmaceuticals in different clinical phases, 2007

Figure 4.22: Key criteria for selecting a CMO, 2006

Figure 4.23: Critical issues when selecting a CMO, BioPlan Associates Survey, 2006

Figure 5.24: Celltrion’s bioreactor capacity in Incheon, South Korea, 2007

Figure 5.25: Revenue by lines of business in 2006 and 2007

Figure 5.26: Revenue by geographical origin in 2006 and 2007

Figure 6.27: Timelines for constructing and selecting high quality clonal cells

Figure 6.28: Different types of culture media

Figure 6.29: A 20L Wave bioreactor (Wave Biotech)

List of Tables

Table 1.1: Top 10 biotech drugs by US sales ($bn), 2005 and 2006

Table 2.2: Examples of production methods for recombinant therapeutic products

Table 2.3: Marketed biopharmaceuticals and their expression platforms

Table 2.4: Plant-based transgenic companies and their pipeline of recombinant proteins

Table 2.5: Therapeutic proteins produced in transgenic animals

Table 3.6: Number of operating facilities per segment 2004 and 2008(estimated)

Table 3.7: New Technology - Modified Production Plant: Kogenate Bayer/FS®

Table 4.8: Capital investment costs for antibody facilities using mammalian cell culture, 2000-2009e

Table 4.9: Cost of inaccurate capacity planning

Table 4.10: Example of a request for proposal (RFP) content

Table 4.11: Typical areas of responsibility as reported by sponsors

Table 5.12: Capacity expansions in mammalian cell culture fermentation

Table 5.13: Capacity expansions in microbial fermentation

Table 5.14: Diosynth Biotechnology, US facilities, Research Triangle Park, NC

Table 5.15: Diosynth Biotechnologies, microbial fermentation and mammalian cell culture volumes, 2007

Table 5.16: Process development and cGMP manufacturing at Avecia, 2007

Table 6.17: Capital investment estimates for antibody production for two different expression technologies

Table 6.18: Comparison of cost per gram estimates at specified production rate

Abstract

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