DOWNSTREAM PROCESSING

In recent years, biomanufacturers have needed to design downstream processing schemes to meet the specific needs of complex biologics such as cell and gene therapies. Current approaches to intensify production titers are putting added pressure on downstream operations to match capacity requirements. And the need for shortened pathways toward product approval from regulatory agencies has biomanufacturers wanting streamlined downstream process lines. Nominees for the downstream category of the 2020 BPI Readers' Choice Awards exemplify this shift in downstream strategy for complex therapeutics.

The Nominees: Continuous production is becoming essential to increase the efficiency of antibody production while reducing the facility footprint. However, it is crucial to control titer in real-time to allow efficient coupling of perfusion upstream with continuous capture. Writers of an article from BPI's September 2019 issue analyze carefully how to address that issue and identify the pros and cons of different methods.

Ensuring that the therapies and vaccines are safe before being injected into a patient is the primary goal of downstream processing. In BPI's October 2019 issue, writers from BMS  discuss how to determine the integrity of viral filters.

In that same issue, a team of scientists from GSK and Sartorius investigate some conditions in which membrane absorbers could be used to purify adenoviruses.

The unique binding mechanism of bispecific antibodies to both tumor cells and T-lymphocytes might lead to new cancer cures soon, and their purification needs to be simplified to allow for affordable treatments. In BPI's May 2020 issue, a team from Chamow and Associates investigates the possibility of capturing bispecific antibodies on hydroxyapatite as an alternative to protein A.

Read on to learn which article has won this year's downstream award. Our congratulations go out to all the nominees this year — and especially to the winner!