バイオプロセスに関する課題への対応

Abstract

Introduction

In the early 2000s, an anticipated shortfall in protein production capacity was averted thanks to breakthroughs in manufacturing approaches and technologies. Today, new challenges and bottlenecks threaten the costeffective and adequate manufacture of protein therapeutics-which constituted a roughly $68 billion market in 2006. Again, new manufacturing approaches and a host of technological developments promise to address these issues.

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Growing demand for protein-based therapeutics, particularly MAbs, has encouraged manufacturers of these drugs to rapidly expand their production capacity. Which companies have built or are planning to build additional biopharmaceutical manufacturing capacity? What factors influence the decision to expand or add new facilities? The need for increased bioprocessing capacity has spawned a market for contract manufacturing organizations. How large is this new industry? How can it serve the biopharma industry? What are the leading CMOs? Manufacturers have several strategic options for sidestepping bottlenecks and rising costs. How can they influence upstream and downstream production processes? What new technologies (e.g., non-mammalian cell lines, disposable purification devices) will make a difference in throughput?

Scope

• Recombinant proteins and monoclonal antibodies: processes and challenges for their manufacture, trends in approvals and sales.
• Mammalian cell culture: Mammalian cell lines and non-mammalian alternatives, bioreactor technology, media formulation, glycosylation.
• Protein purification: Clarification and filtration, affinity ligands, hydroxyapatite purification, disposable purification devices.

Companies Mentioned in This Spectrum Report

• Abbott Bioresearch Center
• A-Bio
• Affinity Life Sciences
• Amersham Bioscience
• Amgen
• Avecia
• Avid Bioservices
• Baxter Biopharma
• Solutions
• Biocon
• Biogen Idec
• BioInvent International
• Biolex Therapeutics
• Bio-Rad
• BioReliance
• Boehringer Ingelheim
• Bristol-Myers Squibb
• Cangene
• Cardinal Health
• Cellectis
• Celliance
• Celltrion
• Centocor
• Chromos Molecular
• Systems
• Chugai
• CMC Biopharmaceuticals
• Cobra Biologics
• Cook Pharmica
• Corixa
• Crucell
• Daiichi Asubio Pharma
• Dainippon Sumitomo
• Diosynth Biotechnology
• Dowpharma
• DSM Biologics
• Elan Pharma
• Eli Lilly
• Eurogentec
• Florida Biologix
• Fluorometrix
• Gala Biotech
• GE Healthcare
• Genentech
• Genzyme Flanders
• GlaxoSmithKline
• Glycart
• GlycoFi
• Glycotope
• Goodwin Biotechnology
• HyClone
• IBA Biologics
• Imclone Systems
• Invitrogen Bioservices
• Johnson & Johnson
• Laureate Pharma
• Lonza Biologics
• MedImmune
• Merck
• Merck-Serono
• MetaBios
• Millipore
• Molecular Medicine
• BioServices
• Nalgene
• Neose Technologies
• New Brunswick Scientific
• Novartis
• Novo Nordisk
• Nunc
• Organon
• Orpegen Pharma
• Pall
• PDL BioPharma
• Percell Biolytica
• QSV Biologics
• Rentschler Biotechnologie
• Roche
• Sandoz
• Sanquin Pharmaceutical
• Services
• Sartorius
• Schering AG
• Schering-Plough
• Selexis
• Siegfried
• SoloHill
• SynCo Partners
• Tanabe
• Viral Antigens
• Vista Biologicals
• Vivalis
• Wave Biotech
• Wyeth
• Wyeth-Ayerst Laboratories
• Xcellerex
• Xoma

Table of Contents

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• Introduction
• Biomanufacturing Overview
  • The Production Process
  • Regulatory Considerations
• No Shortfall in Production Capacity
  • Expansion of Manufacturing Capacity
  • Fewer Approvals Than Expected
  • Improved Technologies, Higher Yields
• Upstream Processes: Mammalian Cell Culture Production
  • Mammalian Cell Lines
  • Bioreactor Technology
    • Bioreactor Hardware
    • Microcarriers
    • Disposables
  • Media Formulation
  • Glycosylation
• Downstream Processes: Protein Purifi cation
  • Clarifi cation and Filtration
  • Affi nity Ligands
  • Hydroxyapatite Purifi cation
  • Disposable Purifi cation Devices
• Outlook for Biomanufacturing
  • Manufacturing Options
  • Pushing the Limits of Production
  • Alternative Expression Systems
  • Importance of Disposables

Tables

• 1. Increases in Therapeutic Protein Manufacturing Capacity
• 2. Contract Manufacturers of Recombinant Proteins and Monoclonal Antibodies
• 3. Marketed Therapeutic Monoclonal Antibodies
• 4. Protein Expression Platforms

Figures

• 1. Worldwide Sales of Recombinant Therapeutic Proteins and Therapeutic Monoclonal Antibodies
• 2. General Bioprocessing Scheme
• 3. U.S. Monoclonal Antibody Approvals, 1997-2006