Cell Biotech Probiotics Receive FDA Safety Certification... "Expecting Export Increase"

11 Types of Proprietary Probiotics Certified GRAS by US FDA

At around 11 a.m. on the 22nd, at the fermentation building of Cell Biotech's Gimpo factory in Gimpo-si, Gyeonggi Province, the humming sound of fermentation equipment echoed throughout the factory. It was difficult to have a conversation with the person next to you, and all employees were wearing earplugs. Employees, fully prepared with sanitary caps, masks, and hygienic clothing, frequently checked the color of the contents through small glass windows at the top of the bioreactors (fermentation tanks).

At around 11 a.m. on the 22nd, in the fermentation building of Cell Biotech's Gimpo factory in Gimpo-si, Gyeonggi-do, lactic acid bacteria are being cultured inside a large cylindrical bioreactor (fermentation vessel).
Photo by Tae-won Choi peaceful1@

The substance inside the bioreactor is a lactic acid bacteria culture. Here, 10 tons of lactic acid bacteria are produced daily. A factory official explained, "After culturing in the bioreactor for about 16 to 20 hours, enough lactic acid bacteria are cultured to be harvested," adding, "We visually check the culture liquid to confirm whether the lactic acid bacteria have been sufficiently cultured." From this cultured liquid, lactic acid bacteria are separated, coated using sugars and proteins, and then freeze-dried to produce lactic acid bacteria powder. The powder is transferred to the finished product building, where it is processed into powder, tablet, capsule, and oil drop forms. Unlike the fermentation building, where machines outnumbered humans due to automation, the finished product building was bustling with people. Middle-aged female inspectors were sorting out defective products from those passing on the conveyor belt. Even products with minute surface cracks were caught by them.

Cell Biotech, which succeeded in mass-producing lactic acid bacteria domestically for the first time in 1995, announced on this day that 11 types of its self-developed lactic acid bacteria recently received the U.S. Food and Drug Administration (FDA) 'GRAS (Generally Recognized as Safe)' certification. FDA GRAS is the highest safety certification system for food ingredients and additives.

FDA's GRAS certification has strict standards, with only about 1,000 certified ingredients in total, among which only 68 are lactic acid bacteria. The certification requires safety and functionality evaluations including ▲whole genome sequencing ▲antibiotic resistance testing ▲toxicity factor testing ▲animal toxicity testing ▲human application trials.

During this certification process, Cell Biotech focused on proving safety by submitting intake data and toxicity test results, along with experimental results showing that each of their 11 Korean-origin lactic acid bacteria strains is safe for human consumption up to 10 billion bacteria per person. Clinical trials confirmed that Cell Biotech's lactic acid bacteria survive even when mixed with spices that have antimicrobial effects. A company official explained that this means the effectiveness is maintained in the intestines of Koreans, who frequently consume spicy foods.

Im Clinicalhyun, Deputy Director of Cell Biotech's Cell Engineering Research Institute, said, "We discovered and developed 100% lactic acid bacteria from traditional Korean fermented foods," adding, "Lactic acid bacteria must survive well in the intestines to provide health benefits, and our lactic acid bacteria showed high survival rates even when exposed to spicy seasonings like red pepper powder."

The glass window at the top of the bioreactor (fermentation vessel). The color of the contents allows you to check whether the lactic acid bacteria have been sufficiently cultured. Photo by Taewon Choi peaceful1@

With this achievement, Cell Biotech has become the company with the most FDA GRAS-registered lactic acid bacteria strains in the world, surpassing Denmark's Chr. Hansen (9 strains), the U.S.'s DuPont Danisco (7 strains), and Japan's Morinaga (6 strains). The lactic acid bacteria certified for Cell Biotech include patented strains GRN 1078 to 1088, which are used as the main ingredients in all 'Duolac' products.

Cell Biotech's research team consists of 47 microbial experts, including 16 PhDs. They continue research and development to discover new functions of lactic acid bacteria beyond the known benefits for gut health. Currently, among the more than 40 countries to which the company exports lactic acid bacteria, Europe holds the largest share, but they plan to strengthen their entry into the U.S. and Chinese markets. CEO Jung Myungjun said, "FDA GRAS certification will be the most powerful weapon to lead the globalization of Korean-origin lactic acid bacteria," adding, "Obtaining this FDA GRAS certification will greatly help increase exports."