Over the past several years, the biopharmaceutical market has grown into a prominent and promising segment of the overall pharmaceutical industry. Its massive current and impending growth has come as a result of the success of several blockbuster drugs and therapies, as well as an equal number of promising candidates in the pipeline. The immense potential in the biopharmaceutical and biotechnological sector also indicates the rising importance of manufacturing capacity within the industry. The costs associated with acquiring manufacturing capabilities are exorbitant and it is difficult for companies with limited finances and capacity constraints to undertake such operations. These hurdles have led many of the smaller players in the industry and certain pharma giants to outsource a significant part of their business operations to contract service providers known as Contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs). These organizations offer significant cost-benefits, access to larger production capacities, and reductions in time-to-market.
But a pertinent issue faced during outsourcing lies within the nature of the biopharma and biotech industry. Unlike traditional small molecules and generics, biopharma and biotech industry manufacturing involves large molecules such as antibodies, antibiotics, vaccines, recombinant proteins, hormones, and cell and gene therapy-related products. These require specialized manufacturing protocols, large capacity bioreactors, stringent quality and sterility assurance parameters, and extensive single-use disposable modules. In addition, considerable skill and experience are required for their production to ensure both quality and viability, at the same time keeping running times optimal. As a result, very few CMOs operate within this niche, and it includes well-known names such as Boehringer Ingelheim, Lonza, Lupin, Cadila, etc. One new notable player that has taken over this space is Samsung Biologics. Established in 2011 as the biopharma CMO arm of the South Korean group Samsung, Samsung Biologics has undergone massive expansion to become the number one biopharma CMO/CDMO since 2018.
(https://www.businesskorea.co.kr/news/articleView.html?idxno=25388)
About Samsung Biologics
Samsung Biologics has won the CMO Leadership Award for seven consecutive years. The company was evaluated on the basis of several parameters such as its most up-to-date manufacturing facility, capacity to meet client demand, proven ability to manufacture API, flexibility to adjust schedule for special requests, timely project management, financial strength and stability, and the capability to provide regulatory filing support. The company consistently ranks in the top space in ratings by official government licensing agencies such as FDA, EMA, PMDA, and others.
Samsung Biologics' first two biopharmaceutical manufacturing plants were built in Incheon. The facilities were located within the Incheon Free Economic Zone (IFEZ) comprising the Songdo and Cheongna regions and Yeongjong Island. Samsung's first plant accommodated six stainless steel bioreactors with an upstream capacity of 5,000 liters each with a total capacity of 30,000 liters. It was designed and built to carry rapid high protein production. Within the plant are suites for upstream, downstream, filling and finishing units, an administration building, and a warehouse with long-term cold storage capacity. The second biopharmaceutical manufacturing plant contains ten bioreactors with an upstream capacity of 15,000 liters each and a total capacity of 150,000 liters. This allowed the company to enter the mammalian cell culture sphere, whose industrial working requirements mandated bioreactor capacities of 12,000 liters or more, a space previously occupied only by Boehringer Ingelheim and Lonza. The completion of the second facility allowed Samsung to offer services such as cell line generation, process and analytical method development, and analytical services at its facilities. The first plant received production approval from the FDA in November 2015 and the EMA in July 2016, while the second plant received FDA and EMA approvals in October 2017 and December 2017 respectively.
Inside Samsung's Third Plant
Samsung Biologics opened its third biopharmaceuticals manufacturing plant in Songdo, South Korea in October 2018. The facility delivered an annual production capacity of approximately 180,000 liters a year and, when combined with the two former units, effectively increased Samsung Biologics' total production capacity to 364,000 liters a year. Thus, its production capacity exceeds Swiss Lonza (260,000 liters) and Boehringer Ingelheim (240,000 liters), making Samsung Biologics one of the world's largest biologics contract manufacturing operators (CMO) at a single site in the world. The third plant completed the validation process in 10 months, taking two months less time than the second plant, despite a 20% increase in production capacity and a 60% increase in facility. The third plant adopted Samsung Biologics' unique design approach. The company used the accumulated data and experience from construction and validation of its first and second plants, which allowed it to shorten the validation period by optimizing the process, and eliminating and minimizing possible errors. The facility supplies biopharmaceutical products to meet growing manufacturing demands from global pharmaceutical companies and the number of pharmaceutical products the company will produce is estimated to be approximately 350 by 2020. It operates throughout the year and offers services to clients, including small-scale batches for clinical trials to supplying large-scale shipments for commercial production. In addition, Samsung is in the process of assessing the possibility of a fourth plant, likely outside South Korea.
Samsung Biologics has CMO/CDMO contracts with major global biopharmaceutical companies, including established brands such as Bristol-Myers Squibb and Roche. The company entered a ten-year contract with Bristol-Myers Squibb in 2018 for manufacturing a commercial antibody cancer drug at its new plant. In May 2020, Samsung Biologics secured additional manufacturing contracts from GSK to enhance its innovative biopharmaceutical portfolio. More recently, San Francisco-based Vir Biotechnology has entered a $362 million manufacturing deal with Samsung Biologics to produce COVID-19 related products. The deal focuses on large-scale manufacturing of monoclonal antibodies against SARS-CoV-2 and is expected to start manufacturing as early as October and produce potential commercial batches of the drug starting in 2021 pending regulatory approvals.
With proven regulatory approvals, the largest single site capacity, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to provide seamless offerings from development and manufacturing, to laboratory testing services at every stage for biopharmaceutical products, while meeting the evolving needs of the global healthcare industry.
