Biologics and Biosimilars

In the battle of controlling healthcare costs, the high cost pharmaceuticals, especially biologics has become an important issue.

Successful production planning requires consideration of cost factors such as manufacturing cost, capital investment to build

new facilities or to retrofit existing ones, as well as the inventory costs. The cost attributed to the opportunity lost in selling the

product or failure to meet market demand is also considered as the inventory cost. Any unplanned downtime could severely affect the

customer service level, if facility utilization is too high. Underutilization of manufacturing facilities conversely suggests a misplaced

investment in capacity. The overexploitation approach was designed to mitigate the above described facility constrains due to its

power of combining the benefits of perfusion and fed batch processing mode with adequate elimination of facility constrains of fedbatch

bioprocessing was done. The key factors considered are: adapting to modular single use technologies for facility design; smallest

mall footprint for upstream processing saves initial investment, significantly; multiproduct facilities to be designed capable of offering

production output in kilograms per month; completely avoiding the use of conventional stainless steel bioreactors and culture revived

from single low-passage cell bank can be expanded for several months without compromising the product quality. With continuous

processing advantage while adapting an overexploitation approach, the cultured cells can be processed up to 60 passages, typically.