BioPhorum has produced a document on the technology and regulatory gaps in the continuous downstream processing of therapeutic proteins.
The Continuous Downstream Processing For Biomanufacturing: An Industry Review paper uses a mAb process as a model system and highlights the gaps that are preventing the use of continuous biomanufacturing.
It contains a gap analysis of a typical continuous mAb downstream process from
primary capture to bulk drug substance and aims to focus industry and supplier efforts on generating solutions.
The identified gaps are grouped into these categories:
- unit operation technologies
- single-use technologies
Common terminology has also been defined to clarify their meaning. It is hoped that closing the gaps identified in this paper will turn the promise of continuous bioprocessing into a reality so that patients, biomanufacturers and suppliers may all