By J. Cappia, C. Langlois, M. Hogreve, A. Hauk, and K. Wormuth
To meet global demand, it is predicted that next generation vaccines will be based on recombinant approaches and be produced in intensified single-use systems (SUS) to increase capacity at reduced costs. However, despite their benefits, SUS for vaccine manufacturing face a number of key regulatory challenges, which require greater reliance by the biopharmaceutical industry on SUS suppliers.
This article details how Sartorius Stedim Biotech (SSB) is leveraging its quality strategy to address these issues by partnering with polymer and film suppliers to combine material science, film extrusion and bag making expertise, allowing in-depth characterization and process control of extractables/leachables substances and particles profiles of its SUS. The article also discusses why process controls, integrity testing and Maximum Allowable Liquid Leakage (MALL) specifications integrated with a solid global supply network will help the biopharmaceutical industry to achieve a more consistent quality supply of SUS for the production of safe, affordable vaccines.