The Unican Concept

摘要

Use of disposable bioreactors in the biopharmaceutical industry has increased gradually over the past several years in pilot, clinical, and production scale facilities (l-4). Reduced time to market in today's drug industry has created a need for cost-effective development and production strategies as well as manufacturing flexibility. When compared with traditional stainless steel equipment, disposable bioreactor and mixing systems have smaller space requirements, are portable, and come presterilized to eliminate the need for preuse sterilization procedures such as steam-in-place (SIP). Additionally, because their product-contacting surfaces are disposable, the need for clean-in-place (CIP) and associated validation is eliminated (4, S). Disposable systems also allow for faster turn-around times in between runs, reduce contamination risks, and ultimately increase flexibility for production facilities.