Samsung BioLogics Receives FDA Approval for Biologic Drug Substance Manufacturing

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This marks the third FDA approval for the company’s second biomanufacturing plant in Incheon, Korea.

On May 24, 2018, Samsung BioLogics announced that it received a third monoclonal antibody drug substance license from FDA for its second biomanufacturing plant in Incheon, Korea. With this approval, the company is now licensed to manufacture three commercial biologics drug substances at its second plant. The plant was approved as GMP ready in 2016.

The company has improved production efficiency by installing ten 15,000-L bioreactors. Previously, the industry had only installed four to six bioreactors in a single biomanufacturing plant, according to the company. The company’s Plant 1 and Plant 2 are compliant with global GMP standards, including FDA, Eurpean Medicines Agency, and Pharmaceuticals and Medical Devices Agency. Plant 2 is five times larger and more complicated to operate than Plant 1 but received initial manufacturing approval six months faster than Plant 1, the company reports.

The company has won the contract manufacturing organization (CMO) leadership award presented by Life Science Leader in all six core categories for two consecutive years.

“There have been some cases recently where CMO’s failure of receiving approval affects the clients’ drug marketing schedule,” said TH Kim, CEO and president of Samsung BioLogics, in a company press release. “Samsung BioLogics has once again demonstrated that it possesses world class quality with data integrity which is critical to get global approvals. Samsung BioLogics has been striving to establish a system to completely prevent even tiny data errors that may occur during the whole production process of biopharmaceuticals from the establishment of the company and to set it up as a corporate culture.”

“We will continue to do our best to continuously innovate ourselves so that clients and patients can receive high quality medical products in a timely manner,” he added.

Samsung BioLogics will be attending the BIO International 2018 Conference in Boston on June 4–7, 2018.

Source: Samsung BioLogics