Samsung BioLogics’ End-to-End service to maximize client satisfaction

Samsung BioLogics was established in April 2011, and is headquartered in Incheon, South Korea. Samsung BioLogics provides an end-to-end service for contracted biopharmaceutical production from cell-line development, process development, and commercial manufacturing of both Drug Substance and Drug Product. The company has constructed three mega plants having a total bioreactor capacity of 362,000 liters. This makes Samsung BioLogics the world’s largest CDMO.

Samsung BioLogics’ endeavors for successful quality management

The company is just over seven years old and has already accomplished remarkable achievements within a short time period. Not only the company is the largest CDMO, it also continues to manage the top quality. It has received 17 approvals from global regulatory agencies including FDA, EMA, and PMDA without a single critical observation.

The success of quality management system is based on several factors like employees and operation competency. Vast majority of Samsung BioLogics’ employees have a science related degree. Also a lot of employees have been working with the company for 7 years. This means that they were here making decisions when the cleanrooms were designed, when the quality equipment was selected and when the equipment and processes were validated. The same people that wrote and executed the validations are now transferring in new products and running the production lines. In addition at Samsung BioLogics, more than 100 of employees are global experts who have in depth experience in regulated pharmaceutical industry.

Not only the employees, but construction competency that Samsung has accumulated from other industries also expedite the growth. Samsung has built 25 semiconductor plants and over 50 petrochemical plants. A lot of senior engineers of Samsung BioLogics are from other Samsung affiliated companies. They applied know-hows on the plant construction, which make the facility as one of the most advanced one in the world.

The company has already experienced clean room operation in semiconductor business. At Samsung BioLogics, a dedicated quality control group monitors every step of the manufacturing process to insure the highest quality.

Samsung BioLogics’ business culture is also created to being the best CMO in the global market. Samsung BioLogics’ upper management support junior level employees through awards and incentives. In the center of this business culture is the passion to produce quality products under our quality management systems.

Samsung BioLogics’ goal: maximize client satisfaction through manufacturing innovation and excellence in execution

By evolving into a provider of contract development and manufacturing services for drug substances and products, Samsung BioLogics has equipped itself to maximize client satisfaction and quality excellence.

Biopharma companies that do not have their own facilities or need to outsource for stable supply typically have to work with multiple companies. Working with multiple companies creates communication challenges and complicated project management. By providing research, development, and manufacturing of Drug Substance and Drug Product under one roof, Samsung BioLogics mitigates these challenges.

Although it has only been in the industry for seven years, Samsung BioLogics is starting to stand out as a reliable partner that clients can rely on. As a result, the company has already signed multiple manufacturing contract with many global pharma companies including BMS, Roche, and Sun Pharma.

By leveraging Samsung’s expertise in plant construction and operation, Samsung BioLogics saved almost 40 percent of CAPEX. As a result of this saving, Samsung BioLogics can provide high quality biologics drugs while reducing cost dramatically.

Not only the cost savings, but also clients can reduce the burden of complicated project management by relying on Samsung BioLogics throughout every steps of biologics manufacturing. With dedicated minded employees, manufacturing innovation, and excellence in execution, Samsung BioLogics employees work eagerly to maximize client satisfaction.