Sunday September 24, 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
Regeneration Studies of Anion-Exchange Chromatography Resins
Quantifying and Qualifying Extractable Substances from Components of Disposable Assemblies
Where Do Standards Come From?
Disposables Qualification and Process Validation
What Is a Generic Biopharmaceutical? Biogeneric? Follow-on Protein? Biosimilar? Follow-on Biologic?
Critical Design Aspects of Single-Use Systems
“Single-Use” Doesn’t Necessarily Mean “Disposable”
Application of Disposable Pressure Sensors to a Postcentrifugation Filtration Process
Quantifying Sterilizing Membrane Retention Performance
A Novel Single-Use Mixing System for Buffer Preparation