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Confronting the Bioprocessing Challenge


Description: 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 cost-effective 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.


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 Purification
Clarification and Filtration
Affinity Ligands
Hydroxyapatite Purification
Disposable Purification 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


Companies Mentioned 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


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