Genetic Engineering & Biotechnology News

NOV1 2018

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 1, 2018 | GENengnews.com Michelle Stafford, Pete Genest, and Randal Goomer, Ph.D. The biologic drug market is projected to reach $390 billion within the next two years, 1 and the need for efficiency and speed may be outpacing the mar- ket. The advent of personalized medi- cine requires smaller batch sizes, while new drug modalities and new produc- tion technologies emphasize the need for adaptable manufacturing environ- ments. Biopharmaceutical manufacturers are seeking dynamic processing eco- nomics that address the paradigm shift from blockbuster drugs with estab- lished, large-batch production schemes to small-scale manufacturing and inno- vative technologies. From Innovation, to Acceptance, to Industry Standard The promise of flexibility and speed that single-use technology brings to a marketplace in continuous change has been realized, and the wide acceptance of single-use systems is evidenced by the growth in this technology. Change- over time between batches with single- use bioprocessing are up to five times faster than the CIP/SIP process re- quired in a stainless-steel environment, enabling production of as many as seven more batches per year. 2 Ballroom or dance-floor implementations with closed-process single-use bioprocessing have further streamlined the logistics of single-use processing by reducing cleanroom requirements for most of the process train. Following early implementations of single-use bioprocessing systems, initial regulatory hurdles were cleared, and guidance for single-use systems has been developed. Regulatory accep- tance and familiarity, in conjunction with the success of early adopters, have driven steady growth in the adoption of single-use systems. The ability to rapidly create and expand capacity by deploying modular single-use produc- tion facilities has proved attractive to emerging markets, 3 as well as to start- ups. There is little doubt that single- use production will be part of every biomanufacturer's strategy moving forward. The challenge now is to gain greater efficiency with smaller scale, flexible production schemes. Driving for pro- cess intensification has become the new operating standard. Given that a 1% improvement in overall process yield can lead to as much as $2.8 million in additional revenue per batch (for a bioreactor titer of 5 g/L with a dosage size of 50 mg), investing in processes and technologies that will increase ef- ficiency is imperative. What's Next? BioPharm 4.0 Efficiency gains with intelligent bio- manufacturing have tremendous po- tential to further advance the benefits of single-use manufacturing. Biopro- cessing with stainless-steel equipment and fixed piping has been automated, to varying degrees, for decades. The Single-Use Technologies for Bioprocessing Evolution of Single-Use Bioprocessing into BioPharm 4.0 GE Healthcare Life Sciences Uses Data Analytics to Drive Continuous Improvements in Efficiency Michelle Stafford is global marketing leader, Pete Genest is director of automation strategy, and Randal Goomer, Ph.D., is staff data scientist at GE Healthcare Life Sciences. Website: www.gelifesciences.com.

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