Tomorrow’s vaccines need to be developed with new sets of technologies. By using modern techniques and cell-based upstream processes it is possible to produce closer to the local market in order to overcome distribution hurdles, as well as to bring down production costs and facility footprint.
Improved manufacturing agility and productivity
Biomanufacturing based on single-use technology offers great flexibility compared with traditional stainless steel facilities. Production lines can more easily be modified for the manufacture of different products and the adaptation of production volumes to meet market needs is significantly facilitated. Furthermore, disposables minimize the risk for cross-contamination between production batches, and the need for time-consuming and costly cleaning and validation procedures is made redundant.
Single-use systems are well accepted in today’s manufacturing industry and their widespread use is driven by benefits such as reduced and delayed capital investments as well as by a shift from fixed costs to variable costs.
Single-use systems allow for quick changeover between campaigns with the opportunity to produce more batches per year. Optimized facility utilization is the key to minimizing production costs and potentially increasing revenue.
Reduced environmental impact
The environmental impact of implementing single-use products in the biomanufacturing process has been widely discussed. One perception is that the environmental impact is greater for disposables than for traditional stainless steel facilities. In a peer-reviewed life cycle assessment (LCA) study, performed by Cytiva in collaboration with Biopharm Services, single-use equipment was compared with conventional stainless steel equipment (3). The environmental impact across the entire life cycle of the product was assessed: from the production of the equipment’s constituent materials and components to the use and ultimate disposal of the equipment. The results from this study showed that a facility based on single-use equipment has lower environmental impact than a facility based on traditional stainless steel equipment. This was shown for all the 18 environmental impact categories investigated. The largest savings identified in the LCA study were shown to be energy demand and water requirements during the use phase.