Single Use Technology in Bio-pharma R&D

New molecule development requires pilot scale studies, which require small volumes of material to support drug product development. The batch size for the manufacture of clinical-trial material is typically a few liters, and the quantities of the bio-pharma active ingredient required is also small. However, due to operation inflexibility in the traditional process, cost saving is not possible. Traditional technology up-gradation is also insignificant for scientists designing or upgrading systems for improving processing efficiencies and throughput time. Drug companies nowadays are focusing more on bio-pharma product development. Currently, there are close to 400 biotechnology drug products and vaccines in clinical trials, which target more than 150 diseases. Companies need to manufacture their product candidate under current Good Manufacturing Practice (cGMP) conditions to conduct clinical trials. R&D cost in bio-pharma is high and there is a need for more efficient technology, as biologics manufacturing is complex and highly regulated by the FDA. [gview file="http://www.beroeinc.com/wp-content/uploads/2015/05/Single-Use-Technology-in-Bio-pharma-RD.pdf"]