Genetic Engineering & Biotechnology News

SEP15 2017

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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20 | SEPTEMBER 15, 2017 | Gerben Zijlistra and Prinka Gupta The manufacture of biopharmaceuti- cals using fully continuous processes has the potential to improve product quality and increase the productivity of biomanufacturing facilities. During batch processes, conditions are always changing as cells grow. Cells reach peak concentration and then decline in viability. These changing conditions can af- fect the product quality of labile prod- ucts and even stable biologics such as monoclonal antibodies (mAbs). Con- ditions within a continuous process tend toward a steady state, so product quality is much more consistent. Increasing productivity can lead to lower cost of goods and the potential to make biologics more affordable, which could improve access to bio- logic treatments for a greater number of patients around the world. The Integrated Solutions team at Sartorius Stedim Biotech (SSB) recent- ly worked on a continuous biopro- cessing project with a small biosimilar company. The process modeling of different scenarios provided powerful insights into the relative drug produc- tion costs using batch and continuous approaches. We identified that the biosimilar company could improve productivity by running higher cell density cell cul- tures that allow a 10-fold increase in titer. We determined that the volumet- ric productivity that can be achieved from a 5K-L bioreactor in a month could be obtained from a 100-L biore- actor operated in continuous mode— 10 kg/month of product could be produced, and this could be achieved with smaller equipment and a lower footprint leading to lower costs. Eliminating Hold Steps The concept developed was to have a small suite with fully connected unit operations, thereby eliminating hold steps. Producing multiple products in a single facility using continuous pro- cessing can be a challenge. Products must be segregated from one another, but unlike during batch processing, this cannot be on a temporal basis, when they are undergoing continuous production. To overcome this chal- lenge, a multiproduct facility can be operated using the ballroom concept with different suites dedicated to dif- ferent drugs (Figure 1). For a small biosimilar company, operating a continuous manufactur- ing process with a smaller footprint is a very desirable option. It allows the companies to compete effectively by allowing them to reach the market CO N T I N U O U S B I O P R O C E S S I N G Moving toward Continuous Bioprocessing Industry Fast Forwards with Hopes of Boosting Productivity and Lowering Cost Figure 1. Ballroom concept with smaller suites doing connected processes from upstream to downstream (where DS is drug substance and DP is drug product).

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