The pipelines of biopharmaceutical companies are becoming increasingly diverse while improvements in cell lines are leading to more productive bioprocesses. These factors are driving new capacity demands for biopharmaceutical companies and their CDMO partners. It is becoming increasingly important, therefore, that companies implement Innovative, highly efficient, flexible facilities that are capable of meeting these challenging capacity demands.
New Biomanufacturing Facilities must meet the following requirements
- Apply single-use technologies for lower capital expenditures (CAPEX), from cell vial to drug product vial and from development to routine manufacturing
- Provide a platform for rapid transition between product development and commercialization
- Ensure rapid start-up and ease of compliance – Be reusable and flexible as process and products change (New manufacturing strategies)
- Allow process transfers readily
- Allow the development of automation and control strategies, including PAT, data analysis, real-time release
- Allow security of supply (single-source vs. multiple sourcing)