BioPharm March eBook - Outsourcing Resources

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26 BioPharm International eBook March 2018 Outsourcing Resources Contract Biomanufacturing 2017 (1). Two months later, EMA licensed the facility (2). E ac h f ac i l it y h a s up st r e a m, downstream, and fill/finish suites, bonded warehousing, as well as process development and quality control laboratories. The company has 50-L, 200-L, and 1000-L bio- reactors for preclinical and clinical production. A third plant—a $740 -million invest ment—was completed in late 2017 and has 180,000-L capac- ity, bringing the company's total capacity to 362,000 L. The com- pany expects it to be operational in 2018 with commercial production starting in 2020. I n 2 017, Sa msu ng BioL og ics added cell-line development, pro- cess development ser v ices, and clinical trial drug manufacturing as additional revenue sources and to satisfy client requests to obtain multiple services from one provider. As of January 2018, the company reported contracts totaling $3.3 billion with 10 drug companies including Roche and Bristol-Myers Squibb (3). WHY BIGGER IS BETTER FOR CMO AND CLIENTS Samsung BioLogics chose to build "jumbo" manufacturing facilities to handle large volume demands and because it saw greater oppor- tunity for differentiation in larger room, Kim said. Building a larger si ze fac i l it y is more comple x; howeve r, t h is approac h of fe r s opportunities to save on capital expend it ures and constr uc tion timelines, if executed properly. Contract manufacturers compete against other CMOs for business but also against drug companies choosing to manufacture in-house. T he lat te r s c e na r io i s not a n apples-to-apples comparison, Kim said, but is "a CMO's dilemma." A CMO's service price—the cost of goods and a profit margin—com- petes against the drug manufactur- er's in-house cost of goods. Variable expenses, such as the cost of sup- plies and materials are borne by the drug company. Therefore, fixed costs of facility expenses and labor costs are key factors in the overall cost of drug manufacturing. Samsung BioLogics was able to use lessons lear ned f rom ot her indust r ies to reduce its capita l e x p e nd it u re s, b u i ld more e f f i- ciently, and reduce the number of operators required to run the plants, Kim said. While the sec- ond plant is five times the size of t he f i r st pla nt, t he nu mb er of operators in the second plant i s on ly 1. 5 t i me s t he nu mb e r employed in the first plant. By ma nag i ng it s f i xe d cost s, Samsung BioLogics can be more comp et it ive w it h ot he r C MO s a nd w it h i n-house d r ug ma nu- facturing, he concludes. REFERENCES 1. Samsung Biologics, "Samsung BioLogics Receives the 1st FDA Approval at the World's Largest Plant," Press Release, Oct. 11, 2017. 2. Samsung Biologics, "Samsung BioLogics Receives the 1st EMA Approval for its Plant No. 2 Production," Press Release, Dec. 13, 2017. 3. Sohn Ji-young, "Samsung BioLogics Says 4th Plant Production Plans 'Still Under Review'," The Korea Herald, Jan. 15, 2018. view.php?ud=20180115000803#cb BP Samsung Bioepis, a joint venture of Samsung Biologics and Biogen formed in 2012, has a pipeline of six biosimilars in immunology, oncology, and diabetes. As of December 2017, five were approved in Europe, four were approved in Korea, two approved for the Australian market, and one each for Canada, Brazil, and the United States. Another candidate received tentative approval in the US, and the filing was accepted by FDA for a third candidate. Based on the company's expertise gained developing biosimilars, Tae Han Kim, CEO and president of Samsung BioLogics, did not rule out a venture into novel biologics drug development. "It is very natural that Samsung might think about novel biologics," he said. "What is impor tant is you should be able to develop novel biologics in a more efficient way either by saving time or development cost or improving the development success possibility dramatically." In August 2017, S amsung Bioepis announced a collaboration agreement with Takeda Pharmaceutical Company to jointly fund and co-develop novel biologic therapies in unmet disease areas. The joint effort would combine Samsung Bioepis' biosimilar development platform and Takeda's drug development expertise (1). Reference 1. Samsung Bioepis, "Samsung Bioepis and Takeda Sign Strategic Collaboration Agreement to Co-Develop Multiple Novel Biologic Therapies," Press Release, Aug. 21, 2017. Venturing Into Biosimilars and Novel Drug Development

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