Saturday December 16, 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
Process Monitoring and Controls
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
November 2005 Supplement
A General Approach to Robustness Studies
Impact of Virus Stock Quality on Virus Filter Validation
Importance of Adequate Controls in Viral Clearance Studies
Meet the Viruses
Methodologies for Viral Safety
Nomenclature Standardization for “Large Pore Size” Virus-Retentive Filters
Optimizing Virus Filter Performance with Prefiltration
Viral Robustness Studies for Biopharmaceuticals
Virological Safety of Biopharmaceuticals
Virus Safety Evaluation of Biotechnology Products in Development