Genetic Engineering & Biotechnology News

MAY15 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 | MAY 15, 2018 | | Genetic Engineering & Biotechnology News GEN: What major advances in purification and recovery have occurred over the past 10 –15 years? Dr. Bulpin: The development of platform processes for monoclonal antibody (mAb) production is a significant advance in puri- fication. Within this framework of relatively standard unit operations, we have been able to maximize the productivity of in- dividual unit opera- tions for capture, purification, virus removal, and for- mulation. This has significantly de- creased process de- velopment timelines and increased manufac- turing efficiency through the commercializing of high-capacity Protein A resins and virus filters, high-selectivity polishing resins, and high-performance ultrafiltration membranes. Single-use technology is advancing the area of purification. The manufacturing flex- ibility and reduction in risk make single-use particularly attractive to biomanufacturers. Impact on capital expenditures, cost of goods sold, scaling-out vs. scaling are additional in- centives for facilities to be redesigned to sup- port single-use technology. Finally, we are seeing the need for next- generation processes to meet new market requirements for process flexibility, speed to market, quality, and cost reduction. Dr. Levison: Over the last decade, we have seen many advances in purification and re- covery, including the introduction of higher performing purification tools. Consumables like chromatography adsorbents have much greater productivity, and filtration media of- fer higher throughput and longer campaign lifetimes than previous versions. On a larger scale, these materials are also now easily in- tegrated into single-use assemblies, helping to streamline processes with minimal connec- tions, and the introduction of novel single- use sensors enables real-time measurement within these newer, more integrated systems. Ms. Gebski: Major advances center on the implementation of flexible, single-use, and ready-to-use tech- nologies and the i m p r o v e m e n t i n the performance of chromatography resins. Single-use tan- gential flow filtra- See Roundup on p18 Imagine you're a biologic molecule moving downstream, passing one bioprocessing "stretch of road" after another, immobi- lizing here, eluting there, squeezing through resins and membranes, and then, finally, reaching the end of your travels along with your fellow molecules, fully concentrated. If you encountered slowdowns and backups along the way, you might have been as frustrated as a car driver stuck in bumper-to-bumper traffic. Even if the drug processing road, stretch by stretch, is in good condition, you could encounter stop-and-go traffic, simply because the merest perturbations in flow can slow everything down. You need not suffer delays at any accident scenes or con- struction sites. If the road is carrying a high enough concentration of biologics—to say nothing of impurities, unwanted cell proteins, leached Protein A, and viruses—waves of congestion can propagate through what should be an unimpeded flow. High-titer-induced slowdowns may be called phantom jams, like their bumper-to-bumper counterparts. To exorcise phantom jams, suppliers of bioprocessing equipment and consumables are paying more attention to traffic management. They're incorporating sensors and process control technology; setting up multiple, process-intensifying chro- matography routes; upgrading single-use technology; and redefining the rules of the road to support continuous processing. These innovations promise happier motoring ahead, to judge by recent projections for infrastructure investment. For ex- ample, according to Markets and Markets, the global membrane filtration market for pharmaceuticals is expected to reach $6.20 billion by 2021, from a base of $3.55 billion in 2016, reflecting a compound annual growth rate of 11.8%. Unfortunately, there isn't a Waze app to show us how biologics traffic is shaping up along any particular route. Instead, one must consult with industry experts. GEN did, and the result is this roundup article. We invite you to ride shotgun. Bioprocessing Feature Andrew Bulpin, Ph.D. Head of Process Solutions MilliporeSigma Roundup Bioprocess Filtration Adjusts for Smooth Flows Christine Gebski Vice President, Product Management and Field Applications Repligen

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