Saturday September 23, 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
April 2004 Supplement
Acknowledgments – Continuing Our Supplement Series
Chapter 1: The Human Immune System
Chapter 2: Classifying Vaccines
Chapter 3: Applying the Technology
Chapter 4: Vaccine Testing and Delivery
Chapter 5: The Two Global Markets
Glossary: The Language of Vaccines and Immunology
Resources for Further Reading