A steady supply of ChiRhoStim (Human Secretin for Injection) has been guaranteed by ChiRhoClin, a theranostics business that specializes in orphan pharmaceuticals for gastrointestinal and radiological applications, in order to satisfy rising demand throughout the United States. ERCP cannulation, gastrinoma testing, pancreatic fluid collection for diagnostic reasons, pancreatic function tests, and the diagnosis of pancreatic cancer and exocrine dysfunction are all made possible by this essential medication. Collaborating with the FDA CDER Drug Shortage Team, ChiRhoClin secured interim approval for the commercial release of the first process performance qualification (PPQ) batch, manufactured and packaged by PCI Pharma Services. The streamlined approval and manufacturing process significantly reduced the time to market by three months.
PCI Pharma Services' Bedford facility handled sterile manufacturing, lyophilization, and quality assurance, while its Philadelphia site oversaw commercial labeling, packaging, and distribution. This cohesive "under one roof" approach expedited production and highlighted PCI's role as a turnkey partner. ChiRhoClin CEO Skip Purich praised PCI for prioritizing ChiRhoStim, ensuring the continued availability of this life-saving diagnostic drug. Moving forward, ChiRhoClin plans to designate PCI as its primary manufacturing and supply partner, reinforcing their shared commitment to advancing healthcare solutions for the pancreatic community.
