There is huge pressure on biomanufacturing facilities due to high demand for gene therapy products such as recombinant adeno-associated viral (AAV) vectors made under current good manufacturing practice (GMP) conditions. The constraints of the scale-up process are rarely taken into consideration during clinical process development, with many facilities simply scaling-out adherent cell stack protocols, procedures, and test methods. In order to demonstrate the importance of cost economics linked to the choice of scale-up processes, this study provides a detailed cost modeling analysis comparing viral vector production in adherent cells in cell stacks to viral vectors produced in bioreactors, either in suspension using a stirred bioreactor or adherently in fixed-bed bioreactor. The results show that single-use bioreactors allow the cost of installed capital and labor to be reduced significantly and that fixed-bed bioreactors with optimized production protocols offer the greatest experimental robustness and the best opportunity for increased productivity in a manufacturing facility.
Modern biotechnology has grown over the last 35 years to a maturing industry producing and delivering high-value biopharmaceuticals that yield important medical and economical benefits. The constantly increasing need for biopharmaceuticals and significant costs related to time-consuming R&D work makes this industry risky and highly competitive. This trend is confirmed by the important number of biopharmaceuticals that are actually under development at all stages by all major pharmaceutical industry companies. A consequence of this evolution is an increasing need for development and manufacturing capacity. The build up of traditional - stainless steel - technology is complicated, time consuming and very expensive. The decision for such a major investment needs to be taken early in the development cycle of a promising drug to cope with future demands for clinical trials and product launch. Possibilities for the reduction of R&D and manufacturing costs are therefore of significant interest in order to be competitive.In this chapter, four case studies are presented which outline ways to reduce significantly R&D and manufacturing costs by using disposable technology in the frame of a the transfer of an antibody manufacturing process, the preparation of media and buffers in commercial manufacturing and a direct comparison of a traditional and a fully disposable pilot plant.
Viral vectors facilitate the delivery of genetic material to living cells for the potential treatment of multiple genetic diseases. With recent regulatory approvals, the rapid growth in demand for viral vector-based products highlights the need for proven, scalable manufacturing solutions that can fully meet this demand and ultimately increase the availability of viral vector-based treatments. Pall's Allegro TM STR stirred-tank bioreactor addresses the need for scalability, as it can be scaled up to 2000 L to enable the manufacture of viral vectors. In this article, we discuss the key attributes of the Allegro STR bioreactor such as the design, scalability, agitation and sparging which make it ideal for viral vector manufacture at a larger scale. Also, we show process scalability under controlled key parameters from Allegro STR 50 L to 500 L based on cell growth, metabolic profile, and viral vector production.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.