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Covering the whole development process for the global biotechnology industry
Upstream
Processing
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.
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Downstream
Processing
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.
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Manufacturing
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.
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Analytical
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.
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Downstream Development
Downstream Validation
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QA/QC
Upstream Development
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Leachables/Extractables/Particulates
Business
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.
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CMC Forums
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BioRegions
Tuesday, August 18, 2015
Daily Archives
Implementing Clone Generation in Fast-Track Manufacturing of Proteins (Video)
by
Guillaume Plane
Page 6 of 6
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