By Terri Love, Senior BioManufacturing Engineer, MilliporeSigma and Youness Cherradi, Senior Process Development Scientist, MilliporeSigma
Single-use systems (SUS) are now used routinely in the manufacture of biologics in both upstream and downstream operations. The biopharmaceutical industry has seen increased use of these technologies over the past decade and this trend continues with a global market expected to grow to over $4.3 billion by 2021.
A recent development is the adoption of single-use assemblies for final filtration. These assemblies have evolved from the first simple assemblies of a capsule with tubing to more complex designs, which enable pre-use integrity testing, blow-down and sampling. Among others, GSK (Barnard Castle, U.K.) and Roche Diagnostics GmbH (Mannheim, Germany) successfully implemented single-use assemblies in their final fill process steps.
At GSK, the main driver for moving from stainless steel to SUS was the need to rapidly meet the intense demands of influenza vaccine production. SUS offered flexibility, robustness, and speed of implementation, and while cost reduction was not the primary concern, SUS were operationally efficient by minimizing the clean-in-place and sterilization needs associated with a multiuse product facility. Implementation of SUS at GSK reduced the campaign fill time from 36 to 12 hours, which led to a 40% improvement in capacity, allowing GSK to manufacture more batches and meet future demand for vaccines.