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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Page 49 of 77

12 | SEPTEMBER 15, 2017 | ➜ Randi Hernandez Although estimates vary slightly, many industry experts predict continuous manufacturing will, at the least, cut the cost of manufacturing biologics in half. Thus, it will be an attractive option for drug makers looking to trim manufacturing budgets. But not all biologics would be feasible candi- dates for a truly integrated processing stream, and a truly continuous line may require a larger initial capital in- vestment. To learn more about which companies and products will likely incorporate continuous manufactur- ing first—and to understand which "hot-button" questions regarding implementation still require atten- tion and clarification—GEN spoke to pioneers in the field of continuous biomanufacturing, including Massimo Morbidelli, Ph.D., professor of chemi- cal reaction engineering at the Institute for Chemical and Bioengineering at ETH Zürich; Andrew Zydney, Ph.D., distinguished professor of chemical engineering, The Pennsylvania State University; Michelle Najera, Ph.D., downstream development scientist, CMC Biologics; Gerard Gach, chief marketing officer, LEWA-Nikkiso America; Dana Pentia, Ph.D., senior application scientist, and John Bon- ham-Carter, director of upstream sales and business development at Repligen; Gerben Zijlstra, platform marketing manager, continuous biomanufactur- ing, Sartorius Stedim Biotech; and Karol Lacki, Ph.D., vice president of technology development at Avitide. Common conclusions from the ex- perts were that the use of surge tanks in continuous lines has both benefits and drawbacks (see the Bioprocessing Perspectives column on page 22 in the September 15 issue of GEN); enzyme- replacement products and monoclonal antibodies (mAbs) will likely be the first product candidate types selected for integrated continuous manufacture (more specifically, mAb-based bio- similars); and manufacturers are less likely to switch legacy products from existing batch processes to continuous operation. The high prices of affin- ity resins are not expected to decline significantly in the near future, and continuous production could result in resin cost savings—but the experts explain there are many benefits of continuous production of biologics besides those related to cost. Most of the products that would likely be made in integrated continu- ous lines will be new products, and will also primarily be labile biolog- ics or those which have uncertain demand. Continuous operation, says Bonham-Carter, will allow engineers to react to fluctuations in product demand and give companies the op- tion to build late (or build out) sig- nificantly, if required. Dr. Morbidelli asserts that peptides, fusion proteins, scaffolds with mAbs, and other prod- ucts "containing sensitive antennary glycostructures that are needed for biological activity" would also be types of therapies that could be made in continuous flows. To tell which pharma manufactur- ers are likely to integrate end-to-end continuous manufacture into produc- tion lines first, investors and industry insiders should follow company patent filings and peer-review articles au- thored by company representatives. As Dr. Zydney points out, manufacturers Integrated Continuous Manufacturing of Biologics: Trends in the Field CO N T I N U O U S B I O P R O C E S S I N G Roundup Biosimilar Manufacturers, Take Note: This Stream Is for You

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