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