Leading CDMO performing sterile drug manufacturing, lyophilization, testing/QA and packaging operations for mission-critical drug.

Philadelphia, PA – PCI Pharma Services – (“PCI”) a leading global contract development and manufacturing organization (CDMO) focused on biopharma’s most complex therapies – is collaborating with theranostics specialist ChiRhoClin, Inc. to avoid the potential shortage of a critical diagnostic drug used to test for pancreatic disease and cancer. Following a high-priority project executed along a tight timeline, an ample, stable supply of ChiRhoStim® (Human Secretin for Injection) continues to be available to benefit patients throughout the United States.

ChiRhoClin is a theranostics company specializing in orphan drugs for the gastrointestinal and radiological fields. Its intravenous product, ChiRhoStim®, is essential for diagnosing pancreatic cancer and exocrine dysfunction. ChiRhoStim® also supports pancreatic function testing, assists with endoscopic retrograde cholangiopancreatography (ERCP) cannulation, enables gastrinoma testing, and aids in collecting pancreatic fluid for diagnostic purposes.

With ChiRhoStim® experiencing unusually high demand, ChiRhoClin worked closely with the FDA CDER Drug Shortage Team to secure approval for the commercial release of the first process performance qualification (PPQ) batch. This batch was manufactured at PCI’s Bedford, NH facility and packaged at its Philadelphia site. Although the commercialization process typically requires three PPQ runs following CDMO tech transfer, interim approval was granted due to the drug’s established commercial status at PCI.

PCI’s ability to serve as a turnkey production partner helped further expedite the process. The CDMO is performing sterile drug manufacturing, lyophilization, final testing and quality assurance release at its Bedford campus, then handling commercial labeling, packaging and distribution operations from its commercial packaging site in Philadelphia. This streamlined, “under one corporate roof” process expedited drug product release and shortened the batch’s time to market by approximately three months.

Considering the time-sensitive project’s success, ChiRhoClin plans to utilize PCI as its primary manufacturing and commercial supply partner for ChiRhoStim® moving forward.

“Our partnership with PCI has been invaluable, and we extend our deepest gratitude for their efforts in making ChiRhoStim® a priority,” said Skip Purich, CEO of ChiRhoClin, Inc. “Thanks to their dedication, the pancreatic community can avoid the hardship of facing a shortage of this critical, life-saving diagnostic drug.”

“For the PCI team, 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,” said Shawn Cain, SVP Development and Manufacturing and General Manager, Bedford Campus. “We thank the ChiRhoClin team for their commitment to life-saving orphan drugs, and for their faith in PCI as we continue to expand our working relationship.”