Clinical trial materials will be produced for an undisclosed American drug manufacturer.
The groundbreaking ceremony for Samsung BioLogics’ Plant 3 was held in December 2015. Construction of this facility was mechanically completed in November 2017. Plant three covers 118,000 square meters (29 acres) and is the largest biopharmaceutical manufacturing facility in the world. It is expected to be cGMP operational by Q4 2018, with commercial operation beginning in 2020. When the plant is fully operational, Samsung BioLogics will have a total production capacity of 362,000 liters and will be the world’s largest biopharmaceutical CDMO.
Even though it has yet to be validated and receive regulatory approval, Plant 3 has its first customer. Samsung BioLogics received its first order for production at the third plant in late February. The client is an undisclosed American drug manufacturer. If the clinical trials for the drug candidate are successful, Samsung BioLogics will also produce the commercial product. The company reports a value for the contract of approximately $148 million if the product is successful in the clinic and moves forward with commercial launch.
“We are excited to enter into this partnership with a fast growing company and very pleased to be chosen to provide a high quality life-saving product to their patients,” said Samsung BioLogics CEO TH Kim. “As products from our Plant 1 (6 x 5,000L) and Plant 2 (10 x 15,000L) facilities mature, Plant 3 will be utilized to supply those with increasing demand to ensure that we continue to meet our client’s demand. We continue to discuss with multiple biopharmaceutical companies for long term partnership in Plant 3. As such, the utilization rate in Plant 3 may ramp up more quickly than anticipated.”