This downstream and manufacturing focused issue features articles on change notification processes for single-use systems; the growth of biosimilars; a QbD implementation in analytical development case study; an examination of using an M-pleat pattern in filtration systems; and an update on viral safety from Editorial Advisory Board member, Hazel Aranha.
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. Perfusion and other approaches have begun to blur the line between upstream and downstream processing (by performing certain separation/clarification duties as part of their function). And separations technology suppliers are offering solutions to the challenge of continuous drug-substance purification. 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.
The US Food and Drug Administration has stated its appreciation of continuous bioprocessing (CBP), and some studies have shown that it can save manufacturers time and money. However, the bioprocessing industry is still reluctant to implement continuous bioprocessing right away. It will be interesting to see which companies will be among the first-movers to harness the competitive benefits. Although few biologics today are made using CBP-enabled equipment (e.g., advanced bioreactors), the industry is changing. For biologics already in production, it…