Merck & Co. reports it will construct a new manufacturing facility in North Carolina to expand its production capacity for TICE BCG, a medicine containing live, attenuated mycobacteria, and used for treating certain forms of bladder cancer.

TICE BCG contains an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis. The TICE strain was developed at the University of Illinois from a strain originated at the Pasteur Institute, a French research institute. Merck became the only manufacturer of BCG for patients in many countries in 2012. Increasing global demand has since outpaced the company’s current maximum manufacturing capabilities. Once this new facility is fully operational, it will triple the company’s current manufacturing capacity, which the company says is expected to support the anticipated demand for TICE BCG for the foreseeable future.

The company, however, pointed to the lead times required to build the facility, gain regulatory approval of the facility, and the manufacturing process for the product itself. “While this commitment is an important step in making sure that adequate supply of TICE BCG is available, completing construction of a manufacturing facility may take approximately five to six years,” said Merck & Co. in an October 14, 2020 statement. “Once construction is complete, and following regulatory reviews and approvals, supplies of TICE BCG will gradually increase over time. This medicine has a lengthy and complex manufacturing process. Each batch takes more than three months to make, 30 days of which is waiting for the growth of bacteria used to make the medicine. Our company will work to complete this project and meet patient needs in as timely a manner as possible.”

The new facility will be part of the company’s existing Maurice R. Hilleman Center for Vaccine Manufacturing in Durham, North Carolina. 

Source: Merck & Co.