Samsung Biologics Achieves New ISO Certifications for Excellence

Samsung Biologics Secures Prestigious ISO Certifications

Samsung Biologics has announced its achievement of new ISO certifications, which spotlights the company's commitment to business excellence and operational integrity. These certifications include the prestigious ISO 37301:2021, focusing on compliance management, alongside renewed certifications for ISO 27001:2022 and ISO 27017:2015, which pertain to information and cloud security.

Commitment to Compliance Management

ISO 37301:2021 Certification

The ISO 37301:2021 certification is a significant milestone that indicates Samsung Biologics' dedication to enhancing organizational governance and adhering to regulatory standards. This recognition reflects the company’s focus on cultivating a culture of integrity within its operations, enabling it to confidently address challenges in its evolving sector.

Strengthening Information Security

In parallel, Samsung Biologics renewed its certifications for ISO 27001:2022 and ISO 27017:2015, which underscore the organization’s relentless pursuit of the highest standards in information security and cloud service management. The ISO 27000 family of standards is recognized globally for its effectiveness in managing data security and privacy—an area in which Samsung Biologics strives to excel, ensuring both client and stakeholder trust.

CEO's Statement on Certifications

John Rim, the CEO and President of Samsung Biologics, expressed pride in obtaining the compliance certification, stating, "We are committed to meeting high standards that cultivate deeper trust with our clients and enhance our competitiveness in the biopharmaceutical industry." He emphasized the company's ongoing commitment to ethical management, maintaining robust security protocols, and continual improvement.

Ongoing Commitment to Excellence

Beyond the newly acquired certifications, Samsung Biologics remains certified in multiple other areas, including anti-bribery management, quality management, and business continuity management. These additional certifications highlight the company’s holistic approach to operational excellence, reaffirming its status as a leader in the biopharmaceutical contract development and manufacturing sector.

About Samsung Biologics

Samsung Biologics (KRX: 207940.KS) operates as a fully integrated contract development and manufacturing organization (CDMO), delivering comprehensive solutions from initial cell line development to final aseptic fill/finish processes. The organization boasts state-of-the-art, CGMP-compliant facilities equipped with both small and large-scale bioreactors tailored to meet diverse client requirements. Recently, the company expanded its capabilities with the completion of Bio Campus I, housing Plant 4, which has a total production capacity of 604 kL. The development of Bio Campus II, featuring Plant 5, is slated for completion in early 2025, adding an additional 180 kL to its biomanufacturing capacity.

In addition to these expansions, Samsung Biologics America enhances the company’s ability to engage closely with its clients located in the U.S. and Europe. The organization consistently upgrades its capabilities by investing in advanced technologies, including an antibody-drug conjugate (ADC) facility and a dedicated mRNA manufacturing facility, further increasing its aseptic filling capacities. Samsung Biologics is committed to being a sustainable CDMO partner, assuring timely and efficient delivery of manufactured products grounded in operational excellence and proven expertise.

Frequently Asked Questions

What significant certifications did Samsung Biologics achieve?

Samsung Biologics achieved the ISO 37301:2021 certification and renewed its ISO 27001:2022 and ISO 27017:2015 certifications, affirming its operational excellence.

Why is ISO 37301:2021 important?

This certification indicates Samsung Biologics' commitment to compliance management and emphasizes organizational governance in alignment with laws and regulations.

What does the ISO 27000 family of standards signify?

These standards focus on managing information security and privacy, and Samsung Biologics follows them to ensure client satisfaction and build trust.

Who is the CEO of Samsung Biologics?

John Rim is the CEO and President of Samsung Biologics, overseeing the company's strategic operations and focus on integrity.

How does Samsung Biologics ensure client trust?

Samsung Biologics maintains high ethical management and security standards, aligning its operations with international compliance and quality management practices.

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