Tuesday September 26, 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
Facility-Design Considerations for the Use of Disposable Bags
Concept Facility Based on Single-Use Systems, Part 2
PART ONE of the concept facility paper by Andrew Sinclair and Miriam Monge, Biomanufacturing for the 21st Century: Designing a Concept Facility Based on Single-Use Systems
A Case Study in Evaluating Biofacility Exhaust Systems
Case Study of a Clinical-Scale cGMP Biopharmaceutical Production Facility
A Case Study in Parenteral Filling
The Basics of Facility Planning
Suite Changeover Involving Diverse Hosts in Multiproduct Facilities
Four Preparatory Steps to Successfully Refurbishing Pharmaceutical Production
Facility Design for Biotechnology Products in the New Millennium