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Confronting the Bioprocessing Challenge
Decision Resources, Inc., March 2007, Pages: 23


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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.

Get the Answers You Need to Shape Your Strategy

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.



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