Product Development Through Commercial Production: Guiding Your Biologic from Start to Finish

Eunyoung Yang, team leader and chief development officer of the business development team, Samsung BioLogics

Samsung is maximizing customer satisfaction by providing customized, cost-effective, and comprehensive development and manufacturing services. It is the number-four company in the world worth, US$92.3 billion, with 672 offices in 91 countries and employing 512,000 people. Samsung provides electronics (its most well-known business), engineering and construction for heavy industries, financial services, and healthcare support including biologics manufacturing, a medical center, and electronic medical devices.

Samsung BioLogics was founded in April 2011 as a one-stop provider of services from cell-line development to clinical manufacturing to commercial manufacturing and production of drug products. It is a fully integrated contract development and manufacturing organization (CDMO) with the largest capacity in the world. Samsung can help with any stage or all stages for any-sized client. It signed a contract with its first client in 2013; in 2015, its second plant was ready for occupancy; and it recently built a third plant that will be ready at the end of 2018 and fitted with innovative electronics. Samsung BioLogics has had unprecedented capacity expansion, getting to a total capacity of 362 kL in seven years. The company also has a large warehouse for storage at low temperatures. Samsung has saved 40% in construction lead time by building plants with concurrent processing technologies, whereas competitors are building plants step by step and taking four years to do so. This is possible through the company’s experience with chemical and semiconductor plants. Plant 1 took 25 months to build; Plant 2 took 29 months to build and start manufacturing. Plant 3 is the most innovative, flexible, and cost-efficient plant; it is currently undergoing validation and will be ready for CGMP manufacturing by the end of 2018. Both stainless steel and single-use bioreactors are available.

Samsung BioLogics has global CDMO partnerships and has created several joint ventures and strategic collaborations with global pharmaceutical partners (BMS, Roche, and Sun Pharma) since its foundation. The company has signed contracts for 29 products from 20 companies and is negotiating for more than 30 other products. Samsung BioLogics promotes a culture of quality in management systems, review, and compliance. The company has accumulated more approvals every year and has gained 13 in 2018 between the FDA, EMA, and PMDA (Japanese Health Authority). Samsung BioLogics received CMO leadership awards in all six categories for CDMOs (capabilities, compatibility, expertise quality, reliability, and service) for two consecutive years (2017 and 2018).

In cell-line development, the company uses the CHOZN platform to generate reliable and cost-effective products for the clinical stage. Lower costs are realized through flexible licensing terms and no royalty payments after commercialization. Samsung BioLogics can develop processes and analytics for you. Its process development tenets are to follow a collaborative process, dedicate a project manager with support from a scientific team, and to use cutting-edge technologies to see your molecule through to commercialization. Finally, the company also can handle your fill and finish needs with vial filling and lyophilization, freezing and thawing, and inspection and packaging. The company offers a timeline from cell-line development to GMP manufacturing of 16 months – or you can choose the fast track, which gets you to the same point in 13 months.

Samsung BioLogics gives clients a competitive advantage with operating efficiencies by maximizing production output and generating high titers, business synergies in construction time and costs, and cost advantages from geographic locations and negotiated contracts with suppliers.