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Confronting the Bioprocessing Challenge

Published by: Decision Resources

Published: Mar. 20, 2007 - 25 Pages

The price of this report has been reduced due to its age. The original price was $2,025 for PDF.

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 Purification

Clarifi cation and Filtration

Affinity Ligands

Abstract

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.

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?

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