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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16 | SEPTEMBER 15, 2017 | Parrish Galliher, Guenter Jagschies, Ph.D., and Amit R. Dua Now representing eight of the top 10 pharmaceuticals based on global sales, biologics are forecasted to grow at a 9% compound annual growth rate (CAGR) and reach $326 billion sales by 2022. 1 To continue producing biologics in an increasingly competi- tive landscape, the biopharmaceutical industry is challenged with the needs to improve productivity, enhance ef- ficiency, and accelerate speed to clinic and market. Therefore, recently the industry has been focusing more at- tention on innovative manufacturing solutions. 2 One promising approach is con- tinuous processing, which has been used for decades for biologics that are unstable in the bioreactor, and exten- sively in other industries. In a recent biopharma industry survey by Bioplan Associates, three-quarters of respon- dents stated they are either evaluating or considering continuous bioprocess- ing (CB). Also, about one-third cited downstream continuous bioprocessing as a top area where suppliers should focus development. 3 The biopharma industry's interest in continuous processing is driven by ex- pectations of reducing cost, improving quality, and increasing productivity. Other industries have used continu- ous processing to improve manufac- turing costs of goods sold (COGS) and process economics. However, published analyses using a process economics model show varied out- comes for bioprocessing (Table 1). The results depended on active phar- maceutical ingredient (API) volume, manufacturing strategy configuration, and whether capital expenditures (CA- PEX), COGS, or both were the high- est priority. 4 For biologics prone to degradation in batch and fed-batch (FB) processes, continuous processing allows capture under stable conditions. There could also potentially be a quality benefit for non-labile molecules such as monoclo- nal antibodies (mAbs). Glycosylation profiles of mAbs can change in batch or FB systems, likely due to enzymatic modification or degradation after se- cretion. 5 For molecules where the gly- cosylation profile is critical to safety or efficacy, continuous processing could be advantageous. Manufacturers are under intense pressure to increase productivity per unit operation or annual capacity (kg/ yr), especially for low-expressing cell lines, impacting both upstream and downstream teams. In addition, pres- sure to produce multiple products in the same facility demands high pro- CO N T I N U O U S B I O P R O C E S S I N G Continuous Bioprocessing: Is It for Everyone? Insights to Help Determine whether Continuous Is the Best Option for Your Bioprocess Strategy GE Healthcare's ReadyToProcess WAVE 25 single-use bioreactor can be used for batch and perfusion cell culture processes.

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