By Mike W Johnson, Bill Scott
Published in: Entegris Whitepaper
Published on: March 17, 2022
Summary Section from The Article: While single-use technology has been widely accepted in the field of medicine and in many areas of biopharmaceutical manufacturing, adoption for BDS packaging has lagged. This is largely due to difficulties in finding materials that do not leach chemicals into valuable drug product and can withstand the temperatures at which drugs are frozen. At the same time and largely because the materials had not been identified, scalable processes for packaging, freezing, storing, and handling single-use containers had not been developed.
The proven benefits of single-use packaging have driven research and development in BDS packaging, and suitable options are already being tested. Manufacturers can now seriously consider single-use bags as a viable and cost-effective option for bulk drug storage at every step of drug development and manufacturing. New systems can now package drugs at any scale, from a few liters during R&D to hundreds of liters during high-volume manufacturing. Innovative packaging materials are now available that will not contaminate sensitive biopharmaceuticals or become brittle at temperatures below -80°C. Additionally, multi-functional systems have been developed to quickly and safely freeze, thaw, store, and transport large-volume single-use bags.
The success of biopharmaceutical manufacturers relies on hitting performance targets at high yields. To reach these targets, new materials and process advancements can reduce both capital and operating expense, as well as the complexity of bulk drug packaging. Sourcing from suppliers with raw materials expertise and a solid understanding of the process requirements is paramount.
Best Practices • Extension • Packaging • Primary • Shelf-Life • Sterile
