BioMAN Activities – Research Area 2

Flexible modular platforms for biotherapeutic production and delivery

Patient-centric approaches such as personalized or stratified medicine may represent the future of medicine if they can be produced in a safe and economical manner. Additionally, the delivery of biologic drugs to patients can be challenging, if not impossible, in many regions of the world. Patients who could benefit from treatments may live in remote regions, under-resourced areas, or face challenging circumstances such as natural disasters that limit access to life-saving drugs. The state-of-the-art approaches to manufacture biopharmaceuticals are not compatible with on-site, rapid manufacturing of treatments on demand. Instead of large, expensive, single-product focused manufacturing sites, facilities that are small and modular with the ability to rapidly switch between products may be required. BioMAN affiliated researchers are working on a new approach for producing biologics on demand called Integrated and Scalable Cyto-Technology (InSCyT). This platform emphasizes an integrated, milliliter-scale table-top system for (semi)continuous operation, consisting of a parallel set of microbioreactors, filtration of cell debris from secreted product, innovative affinity-based purification, polishing, and finishing, as well as integrated on-line PAT and process control for QbD production and product qualification for release. This approach to manufacturing should supplement traditional processes to improve global access of drugs, and to accelerate drug development.
 
For more information, please see the article in MIT News.
 
We would like to thank the Defense Advanced Research Projects Agency (DARPA) for their support of this research effort.