Wednesday September 20, 2017
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Covering the whole development process for the global biotechnology industry
Bioprocessing begins upstream, most often with culturing of animal or microbial cells in a range of vessel types (such as bags or stirred tanks) using different controlled feeding, aerating, and process strategies.
Cell Culture Media
Perfusion Cell Culture
Upstream Contract Services
Upstream Single-Use Technologies
Beginning with harvest of material from a bioreactor, downstream processing removes or reduces contaminants to acceptable levels through several steps that typically include centrifugation, filtration, and/or chromatographic technologies.
Downstream Contract Services
Downstream Single-Use Technologies
Drug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in liquid or lyophilized (freeze-dried) packaged forms — with the latter requiring reconstitution in the clinical setting.
Manufacturing Contract Services
Many technologies are used to characterize biological products, manufacturing processes, and raw materials. The number of options and applications is growing every day — with quality by design (QbD) giving impetus to this expansion.
Even as it matures, the biopharmaceutical industry is still a highly entrepreneurial one. Partnerships of many kinds — from outsourcing to licensing agreements to consultancies — help companies navigate this increasingly global business environment.
Pre-Clinical and Clinical Trials
September 2006 Supplement
Quality Control Testing
Requirements for Outsourced Cold Chain Logistics and Storage in Biopharmaceutical Development
Successful CMO Selection
Technical Transfer of Manufacturing Processes from Client Sites to a CMO
The Development Journey
The Future of Bio-Outsourcing
The Many Roles of Service Providers
A Practical Model for Outsourced Biomanufacturing
Best Practices for Outsourcing Pharmaceutical Information Technology
Contract Service Providers