PCI Pharma Services, a CDMO, and the biotech ChiRhoClin inked a collaboration deal to address the potential shortage of a critical diagnostic drug used in testing for pancreatic disease and cancer.
ChirRhoClin’s ChiRhoStim drug is used for diagnosing pancreatic cancer and exocrine dysfunction, supports pancreatic function testing, assists with endoscopic retrograde cholangiopancreatography cannulation (which uses an endoscope and X-rays to examine and treat the liver, gallbladder, pancreas and bile ducts) and aids in collecting pancreatic fluid for diagnostic purposes.
The drug has seen unusually high demand, and the company said in a Nov. 19 press release that it is working with the FDA’s drug shortage team to gain approval for the commercial release of the first process performance qualification (PPQ) batch. This batch was produced at PCI’s Bedford, New Hampshire, facility and packaged at the company’s Philadelphia site.
Typically, the commercialization process demands three PPQ runs in the wake of a CDMO tech transfer; however, interim approval was granted due to ChiRhoStim’s established commercial status.
“It is a true point of pride to assist with mission-critical, time-sensitive projects such as this – ones that lean upon our strengths as a flexible, turnkey partner capable of combining precision, quality, and speed to market,” Shawn Cain, a PCI senior vice president at the Bedford campus, said in the release.
Although financial details of the partnership weren’t disclosed, ChiRhoClin said it would use PCI as its primary manufacturing and commercial supply partner for ChiRhoStim moving forward.
Boosted by new business, Philadelphia-based PCI has been on an expansion tear this year. In September, the company said it was investing more than $365 million into a number of manufacturing facilities in the U.S. and Ireland. The company has plans for new drug delivery tech at its Philadelphia headquarters, a 545,000-square-foot expansion in Rockford, Illinois, acquisition of a new packaging and device assembly plant near Dublin and to break ground on another site at its CityNorth Dublin campus.