As a contract development and manufacturing organization (CDMO), Samsung Biologics partners with pharmaceutical companies to scale production and accelerate timescales for the manufacture of biologic medicines. To demonstrate its commitment to its partners, the CDMO has received several certifications from the International Organization for Standardization over the course of its 11 years of operations, with certifications in areas ranging from sustainability to corporate governance.
In October 2022, Samsung Biologics announced its latest efforts on this front, reporting its renewal of the ISO 27001 certification (Information Security Management System), as well as its reception of ISO 27017 (Information Security in Cloud Services) and ISO 37001 (Anti-bribery Management Systems).
“We are extremely proud to add the additional global ISO certifications,” said John Rim, CEO and president of Samsung Biologics. “These latest certifications are in show of our commitment to meet the strongest security standards and our dedication to further enhance client trust and satisfaction.”
Samsung Biologics was awarded the certifications in a ceremony held with the British Standards Institution and the British Embassy Seoul at the CDMO’s Songdo, South Korea, headquarters, where it was also awarded BSI’s Excellence Award for Integrated Management System. The award recognizes outstanding business performance based on international regulations.
Demonstrating CDMO Capabilities
With the new certifications, Samsung Biologics now has a total of eight ISO certifications. These include recognition in areas such as environmental management, energy management, business continuity, occupational health and safety, and quality management.
The range of certifications reflects Samsung Biologics’ focus on building a reputation as a well-rounded, trusted CDMO partner.
Information security certifications are particularly relevant for establishing this trust. Because a CDMO’s business model involves building manufacturing partnerships with other companies in the industry, establishing a reputation for commitment to securing partner companies’ proprietary data is essential.
The anti-bribery certification comes amid Samsung Biologics’ efforts to optimize corporate governance as part of a ramped-up environmental, social, and governance program.
“Amid the growing attention on ESG around the world, which puts a greater focus on the roles and responsibilities of corporations, Samsung Biologics is making a full-fledged effort to establish an ESG-driven management structure by doubling our environmental, social, and governance activities, publishing the ESG report, and establishing an ESG committee,” wrote Rim in the CDMO’s 2022 ESG report. “Samsung Biologics will upgrade its governance structure and deliver a more stringent quality management to enable a sustainable business. Moving forward, we will carry out responsible management and disclose information, and communicate in a transparent manner to boost both internal and external confidence in Samsung Biologics.”
Building on Trust
Founded in 2011, Samsung Biologics has expanded at a rapid pace in its first 11 years, and a key enabling factor of this growth is the CDMO’s reputation as a trusted manufacturing partner. With its newest certifications, Samsung Biologics is bolstering this reputation at a time of significant advancement for the company.
In his 2022 letter to shareholders, Rim outlined a multidimensional growth strategy for Samsung biologics, highlighting plans for diversifying its portfolio, expanding its international footprint, and increasing its manufacturing capacity.
With these goals in mind, the CDMO has completed several expansion projects in 2022. This includes an mRNA production suite that provides end-to-end services from drug substance to drug product, which completed its first commercial-scale production run in August, as well as the full acquisition of biosimilars company Samsung Bioepis, which had previously been run as a joint venture with Biogen.
Perhaps the CDMO’s most significant development in 2022 has been the commencement of GMP operations of its fourth biomanufacturing plant in Songdo. The plant —the world’s largest, with a projected 240,000 liters — is Samsung Biologics’ latest move to establish itself as an industry leader in biomanufacturing capacity. The CDMO will offer a total of 604,000 liters across its facilities in Songdo when Plant 4, which began partial operations in October, becomes fully operational in 2023.
Samsung Biologics also recently announced the acquisition of 357,366 square meters (about 88.3 acres) of land in Songdo for the construction of a second Bio Campus, a facility that will be 30% larger than its current Bio Campus and will further boost manufacturing capacity along with hosting an open innovation center.
The CDMO’s expansion and revenue growth in recent years has been a function of its ability to continue to secure contracts with a diverse variety of partners in the pharmaceutical industry, and these contracts are grounded in a trust that Samsung Biologics can deliver quality results securely. As such, the company’s development goes hand in hand with its ability to demonstrate its capabilities with both results and certifications such as its recent ISO certifications.
“This past quarter saw strong performance and growth due to a consistent momentum in signing new contracts, helping us meet client demand for integrated offerings and deliver long-term value,” explained Rim in a statement on the CDMO’s Q3 2022 earnings report. “Not only have we delivered on our commitments by commencing GMP operations of Plant 4 within just 23 months from the start of its construction, we have also developed and launched our next-generation biotechnologies — S-DUAL™ and DEVELOPICK™ — which will help streamline and accelerate the antibody development process to save time and cost for our clients.” Samsung Biologics’ earnings for the fiscal year have now surpassed KRW 2 trillion (approximately $1.4 billion), and it will look to carry its momentum into continued growth in 2023, pursuing this growth on a foundation of sustainability and accountability, represented by its recent certifications and commitment to ESG policies.
