BPI Lab: Essential Technologies for Development, Characterization, and QA/QC
BioProcess International and BioTechniques partnered to create this special eBook, highlighting and detailing fourteen analytical technologies that provide laboratory technicians and scientists with vital information to help project managers and engineers make educated decisions that ultimately affect every companies bottom line.
Continuous Processes: Disposables Integrate Upstream and Downstream Processes
Perhaps the “hottest” buzzwords in biomanufacturing today are continuous processing and single-use technologies. They are closely related — as one is increasingly enabled by the other. Alongside a review of these advancements by BPI’s senior technical editor, contributed articles will expand on continuous upstream/production methods and continuous downstream processing technologies.
A biosimilar biotherapeutic product is similar (but not identical) in terms of quality, safety, and efficacy to an already licensed reference product. Unlike generic small molecules, it is difficult to standardize such inherently complex products based on complicated manufacturing processes. Table 1 describes the main differences between biosimilar and generic drug molecules. The global biosimilar market is growing rapidly as patents on blockbuster biologic drugs expire (Table 2) and other healthcare sectors focus on reduction of costs. Biologics are among…