Samsung Biologics
| Samsung BioLogics CI_Eng.jpg | |
 Samsung Biologics | |
| ISIN | 🆔 |
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| Founded 📆 | |
| Founder 👔 | Dr. Tae Han Kim |
Area served 🗺️ | |
Key people | Dr. Tae Han Kim |
| Members | |
Number of employees | |
| 🌐 Website | https://samsungbiologics.com/ |
| 📇 Address | |
| 📞 telephone | |
With today's focus on medical advancement from the natural world, Samsung Biologics was founded in April of 2011 to meet increasing demand for biopharmaceutical research, development and manufacturing. With the first cutting-edge manufacturing plant achieving DS cGMP-ready status in June of 2013, Samsung Biologics quickly formed its first strategic manufacturing partnership with Bristol-Myers Squibb the following July. Plant 1 reached DP cGMP status in August 2013, at which point construction of Plant 2 began in September of the same year, followed by a strategic manufacturing partnership in October with F. Hoffmann - La Roche.
April 2014 saw a new level of partnership with Bristol-Myers Squib as they launched a strategic manufacturing partnership in fill & finish. Plant 1 received PLI approval in October of 2015, reaching FDA approval in November of that year - the same month that construction of Plant 3 was initiated. February of 2016 saw Plant 2 reach DS cGMP-ready status, while November of the same year saw Plant 1 achieve EMA approval and the company offered its initial public offering on KOSPI.
May 2017 realized the first PMDA approval of Plant 1, followed by a strategic manufacturing partnership with Sun Pharma in July and FDA approval of Plant 2 in September. October 2017 provided the opportunity for an MOU for a strategic alliance with Merck, while December saw the first EMA approval of Plant 2.
In April 2018, Samsung Biologics received ISO 22301 certification (BCMS), with Plant 1 receiving first approval by Health Canada. GI Innovation formed a strategic development partnership with Samsung Biologics in June 2018, which was followed in July by a strategic manufacturing partnership with UCB. 2018 also saw the first DP approval by the FDA in July, Plant 3 achieving cGMP-ready status in October, and achievement of AEO certification in October. March of 2018 saw a strategic development partnership with Eutilex, followed in April by a strategic manufacturing partnership with CytoDyn. In November 2019, Samsung Biologics received its ISO 27001 certification.
Company Leadership[edit]
Throughout the company's growth, Dr. Tae Han Kim has been at the helm, acting as CEO of Samsung Biologics. Beginning his career with Samsung in 1979, Dr. Kim has a doctoral degree in chemical engineering from University of Texas, Austin. Dr. Kim oversaw the business and financial restructuring of Samsung General Chemicals from 1997 to 2003. Following the establishment of a joint venture, he led the development and implementation of several expansion projects, including a naphtha cracking center, polypropylene and styrene monomer production plants and an aromatics plant.
Vision[edit]
Focused on delivering quality first, Samsung Biologics' vision is to become the most competitive CDMO while rapidly increasing its capability for innovation, quality and capacity, making it possible for clients to receive fast, cost-effective biological medicines. As the company implements current industry best practices, it strives to deliver higher industry standards for biopharmaceutical manufacturing. The company’s unique continual-processing platform allows it to reach superior quality and execution standards for compliance with many global regulatory bodies.
