Tag: <span>product standardization</span>

Single-use systems (SUS) have been employed in biopharmaceutical manufacturing for over 15 years. Consistent year-to-year growth has been seen both in the total volume of sales and the number of manufacturing steps in which SUS are being used. It is projected that the majority of commercial-scale biologics manufacturing will be done in disposable equipment in the near future because of improvements in SUS design and innovation. These devices can significantly reduce capital costs (for example, stainless steel vessels), eliminate equipment cleaning and sterilization, improve turnaround times, and reduce concerns about microbial contamination within a production facility. As reported in this year’s 8th Annual Survey of Biopharmaceutical Manufacturing, however, the rate of growth in SUS use may be slowing. Contributing factors are: 1) the economy; and 2) the need for more consistent product standardization (e.g., design, quality, and leachables/extractables [L&E]) data that regulators and industry end-users can accept with confidence…