Current status and future trends for disposable technology in the biopharmaceutical industryCurrent status and future trends for disposable technology in the biopharmaceutical industry

摘要

Single use technology (SUT) is in widespread use throughout the biopharmaceutical industry where it is replacing traditional stainless steel plant particularly for the manufacture of small volume, high value products. The key drivers for SUT uptake include reduction of regulatory risk, lower capital and energy costs and increased facility flexibility. Disposable technology is now well established for cell culture, liquid handling and storage but its application to some downstream operations is proving more intractable. Single-use chromatography resins are generally uneconomic at process scale and there are limitations on large-scale tangential flow filtration capacities. The development of disposable sensor technology is lagging behind that of bioreactors and capacities for microbial culture are presently limited to 2000 litres. Concerns regarding compatibility of equipment from different suppliers and extracta ble and leachable testing are being addressed but continue to influence uptake of SUT by traditional manufacturers. Complete 'plug and play' disposable process trains, however, are becoming increasingly available and are being embraced by Contract Manufacturing Organisations (CMOs) with multiproduct facilities.