Samsung BioLogics has become the world's top contract manufacturing organization (CMO) as its third plant starts operation.
Samsung BioLogics announced on October 1 that its third plant, the world's single largest biopharmaceutical manufacturing facility, has completed a self-validation process and will start operation based on current good manufacturing practice (cGMP) requirements. cGMP refers to the quality control standards of pharmaceuticals approved by the U.S. Food and Drug Administration (FDA).
The third plant has an annual production capacity of 180,000 liters, which is the world’s largest for a single plant. It boosts Samsung BioLogics’ annual production capacity to 362,000 liters, including the first plant (30,000 liters) and the second plant (152,000 liters). Its production capacity exceeds Swiss Lonza (260,000 liters), a leading CMO company, and Germany's Boehringer Ingelheim (240,000 liters).
In particular, the third plant completed the validation process in 10 months, taking two months less time than the second plant, despite a 20% increase in production capacity and a 60% increase in facility. This was possible because the company used know-hows gained from the operation of the first and second plants
The third plant adopted Samsung BioLogics’ unique design approach. The company used the accumulated data and experience from construction and validation of its first and second plants. This allowed it to shorten the validation period by optimizing the process, eliminating and minimizing possible errors.
The validation process requires collecting and testing of an average of 1,200 samples per day, and one error requires an extra week to rework and revalidate.
With the validation completed, the third plant will run cGMP-based production for two years to obtain a global approval of manufacturing. Afterwards, it will obtain an approval of manufacturing biopharmaceuticals and start the production.
From the validation, Samsung BioLogics secured about 4,500 validation case records. These records are essential for future global manufacturing approval processes, and the self-validation can be seen as the first step for manufacturing approval and production.
Meanwhile, Samsung BioLogics signed CDMO contracts with 24 companies for 33 products as of the end of September 2018. Since the acquisition of its first global manufacturing approval in November 2015, the company obtained an approval every two months, which adds up to a total of 19 production approvals.