University Manufacturing Facility Sees Opportunity in Rare Disease Niche

Rare Daily Staff

The University of Tennessee Health Sciences Center is near completion on its effort to convert a warehouse on the eastern side of its campus into a $20 million pharmaceutical manufacturing facility that will target rare disease drugs.

The Plough Center for Sterile Drug Delivery Systems will be used state-of-the-art facility for manufacturing drugs and training students and professionals from the pharmaceutical industry, as well as employees of government regulatory agencies in pharmaceutical production.

Though it will serve as a training facility, it will also be a contract manufacturing organization focused on producing drugs for preclinical, early-, and mid-stage clinical trials, particularly in the rare disease space. That, according to Ken Brown, executive vice chancellor and chief operations officer for UTHSC, is a niche that the facility will be well suited to address.

He hopes to capitalize on the growing interest among drug companies to develop orphan drugs, but that small quantities need to address their needs that make them unattractive pursuits for CMOs geared to producing large volumes of pharmaceuticals.

“The problem for orphan drug manufacturers is that it’s such a small scale that large commercial manufacturers just don’t want that small book of business,” he said. “Pharmaceutical manufacturing is a large volume business.”

Initially, the facility will focus on producing small-batch drugs in injectable and semi-solid dosage, although Brown said the facility will look at other types of manufacturing and may expand it abilities to include biologics and has even had discussions with a company to do 3D stem cell printing.

“The University’s focus with the new facility will be the development and manufacture of unique drug products with innovative drug delivery systems,” said Brown. “The Plough Center hopes to become recognized for its ability to formulate and manufacture difficult to produce new drug products for clinical trials and for paving the way for manufacturing medicines of the future such as antibody-drug conjugates, nanoparticles and biosimilars.”

The building includes three 800-square-foot prefabricated pods that serve as sterile environments for manufacturing pharmaceuticals. The pods provide cleanroom space and incorporate areas for component preparation, compounding/formulation, filling and lyophilization for use in the manufacturing of clinical and small-scale products. An additional POD will provide cleanroom space for the manufacturing and development of semi-solids products. The building also houses about 10,000 square feet of support labs, offices, and training facilities.

September 18, 2017