Continuous Manufacturing Abstracts

The Shrinking Footprint – Next Generation Technologies in Biomanufacturing; A Case study in the Application of Continuous Manufacturing

Sam Guhan, Ph.D
Amgen

Across the biopharmaceutical industry, a combination of new highly potent modalities and increased competition have resulted in highly dynamic drug demands which necessitate a nimble manufacturing strategy that can quickly respond to changes in market dynamics.  "Next-Generation Technologies in Biomanufacturing" should deliver flexible and reconfigurable manufacturing systems for producing drug substance and drug product. This presentation highlights some of the enabling technologies that could be deployed - including modular construction, single-use bioreactors, disposable containers, connected purification processing, and real-time product attributes analysis. Furthermore, a case study in continuous manufacturing is presented which demonstrates significantly increased productivities for a biologic that enables shrinking the facility footprint while still meeting product demand for patients. The impact of long-term cultivation on product quality and product stability is also presented which collectively demonstrate the feasibility of achieving much higher productivities using Next-Gen Biomanufacturing Technologies without adverse impact on product quality and stability.