Continuous downstream processing is increasingly seen as a feasible approach for manufacturing biologics. The industry recognises that it offers advantages over batch-based processing by:
- producing products with a more consistent quality attribute profile
- allowing greater flexibility to react to changes in market demands
- reducing up-front capital investment in facilities
- optimizing the cost of goods.
However, despite these potential benefits, continuous processing has not yet been adopted for clinical or commercial production.
So what is blocking the use of this new way of working?
To explore the reasons, BioPhorum has produced the Continuous Downstream Processing For Biomanufacturing: An Industry Review, which outlines the technology and regulatory barriers in the continuous downstream processing of therapeutic proteins. This new roadmap chapter complements the existing BioPhorum Technology Roadmap documents and builds on the Process Technologies recommendations around continuous manufacturing.
It contains a gap analysis of a typical continuous monoclonal antibody (mAb) downstream process, from primary capture to bulk drug substance, and aims to focus industry and supplier efforts on generating solutions.
“For us, the draw for participating in the Continuous Downstream Workstream is that it is a group of expert end-users, vendors and integrators, which is building a consensus on the challenges confronting the biopharmaceutical industry for adopting the next manufacturing revolution,” said Charles Heise, Subject Matter Expert – Primary Separations and Filtration at FUJIFILM Diosynth Biotechnologies.
“The value is in differentiating between perceived and real gaps and prioritizing them to help focus problem-solving activities that will enable or maximize the benefit of continuous manufacturing,” added Heise.
The team worked on a common language for continuous processing and believes the gap analysis can be used to address the issues that are stopping it from becoming mainstream. More than 100 gaps were identified and grouped into these categories:
- unit operation technologies
- single-use technologies
The processes for making many biotherapeutics use identical or similar purification technologies, process monitoring and control, and regulatory frameworks, and so the discussions in the roadmap can easily apply to other protein therapies.
The lessons learned from implementing continuous processing for mAbs will, therefore, also accelerate its adoption for other recombinant medicines and vaccines, and new approaches such as cell and gene therapies.
By removing the roadblocks, a framework for continuous downstream mAb processes can be used to lower costs, reduce time to market, allow flexible manufacturing and increase product quality and safety – across the whole biopharmaceutical industry.