Samsung BioLogics gets FDA certification

By Kang Seung-woo

Samsung BioLogics’ second plant has received its first manufacturing approval for a biologic drug from the U.S. Food and Drug Administration (FDA), the company announced Thursday.

With the latest certification, the Incheon-based company is now able to produce nine commercial biologics products -- eight from the first plant and one from the second.

Samsung completed building the second plant with a capacity of 150,000 liters in February 2015 and began pilot production in February 2016. It carries extra weight because it took 19 months to get its first FDA approval, compared with the first production facility, with a capacity of 30,000 liters, which took 25 months for its first certification.

“As for biologics, it is the most important to launch a product ahead of rival companies, so a shorter period before getting licensed by the FDA or other organizations will help us gain the upper hand in the market,” said a company official.

“The second plant is a much more complicated facility than the first factory, but we could shorten the period thanks to its design and operation technology that maximizes production efficiency and ensures the highest quality product for the patient.”

According to the company, the second plant is the industry’s first with 10 bioreactors -- four to six bioreactors are the norm.

With a total of nine approvals from the European Medicines Agency (EMA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) as well as the FDA, Samsung has proved that all its facilities are compliant with global good manufacturing practice (GMP) standards, the firm said.

“We are eager to maintain and further improve our biopharmaceutical quality systems and manufacturing process in a GMP-certified manufacturing facility to provide high-quality products to our clients,” said CEO Kim Tae-han.

“We continue to be dedicated to exceeding the strictest quality standards and our customers’ expectations.”

The FDA approval came as the U.S. agency has increasingly issued warning letters to biopharmaceutical contract manufacturing organizations (CMOs) -- 43 cases in 2015 and 102 in 2016.

The letter is sent when the FDA finds a manufacturer has violated some rule in a regulated activity.

In April, Swiss firm Lonza had its cell therapy facility in the United States slapped with a warning letter and Celltrion received an FDA Form 483 last month. The form is issued to management at the conclusion of an inspection when an investigator observes any conditions that may constitute violations of the Food Drug and Cosmetic Act and related acts.

Samsung BioLogics has invested $740 million for a third plant with a capacity of 180,000 liters and expects construction will be completed by the fourth quarter of this year.

Once the third plant with advanced technology including 3D modeling is operational in 2018, Samsung is expected to have the world’s largest capacity for a biologics CMO, with a total production capacity of 360,000 liters.