Specific phenomena critical to scale-up are listed to help to identify and test for scale-up risks.
The discussion indicates that process simulation as a stand-alone tool does not provide a direct shortcut to successful design and scale-up, but if utilized in a proper way, it will contribute to reducing scale-up risks.
Higher risk programs will either face regulatory rejection, or be assessed scaled up risk payment.
In order to reduce the HIV epidemic among adolescents, a strategic approach targeting adolescents at greatest risk and ensuring scale up of high-impact interventions for adolescents is therefore essential.
Plant systems offer advantages over conventional expression platforms in a number of areas, including low production cost, easy and quick scale-up, low risk of product contamination by mammalian viruses or blood-borne pathogens, and an overall higher quality of products.
They can help speed translation of new biological discoveries to market and reduce risks encountered in scale up.
SURE combines the chemist's process knowledge and the engineers knowledge of large-equipment functionality to come to a balanced, shared, long-term view of the risks to successful scale up.
Biotech Scale Up: People.
