ABSTRACT
The adoption of disposable components in downstream bioprocessing has been an evolutionary process with a few revolutionary peaks. It started with buffer bags and devices for normal flow filtration, including virus filtration and guard filters for chromatographic columns, but gradually, more complex concepts have been introduced, including disposable devices for tangential flow filtration and chromatography in downstream processing. Today, downstream processing science is developing more rapidly than upstream science; more recently, the use of membrane adsorbers has been recommended for large-scale purification of antibodies. Despite the clear demand for downstream processing steps that can provide high levels of viral reduction, few new techniques have surfaced to complement or replace the approaches common in today’s biotechnology manufacturing processes. The key to a successful ultraviolet bactericidal intervention is to introduce it at an early stage of downstream processing so that most aggregates or variant species formed as a result of ultraviolet bactericidal exposure would be cleared in the subsequent polishing steps.
