- PCI Pharma Services is collaborating with ChiRhoClin, Inc. to ensure a stable supply of ChiRhoStim, a critical diagnostic drug used in pancreatic disease and cancer testing.
- PCI has expedited the manufacturing process by serving as a turnkey production partner, shortening the batch’s time to market by three months.
PCI Pharma Services has announced a successful collaboration with ChiRhoClin, Inc., a theranostics specialist, to prevent a potential shortage of ChiRhoStim (Human Secretin for Injection), a critical diagnostic drug used for testing pancreatic diseases and cancer. The partnership aims to maintain a stable supply of the drug, which is crucial for diagnosing pancreatic cancer, exocrine dysfunction, and conducting other vital pancreatic function tests.
ChiRhoStim is an intravenous product used in various diagnostic procedures, including endoscopic retrograde cholangiopancreatography (ERCP) cannulation and gastrinoma testing. The product has been experiencing unusually high demand, prompting ChiRhoClin to work closely with the FDA CDER Drug Shortage Team to secure approval for the first process performance qualification (PPQ) batch. This batch was manufactured at PCI’s Bedford, New Hampshire, facility and packaged at PCI’s Philadelphia site.
As part of the collaboration, PCI’s role as a turnkey production partner expedited the production process. The company handled sterile drug manufacturing, lyophilization, final testing, and quality assurance release at its Bedford facility, while managing commercial labeling, packaging, and distribution at its Philadelphia site. This streamlined approach significantly shortened the time to market by approximately three months, allowing ChiRhoStim to reach the market sooner and prevent a shortage of this essential diagnostic tool.
“We are deeply grateful to PCI for making ChiRhoStim a priority and for their unwavering support in helping us meet the urgent demand for this critical drug,” said Skip Purich, CEO of ChiRhoClin, Inc. The success of this time-sensitive project has led ChiRhoClin to designate PCI as its primary manufacturing and commercial supply partner for ChiRhoStim going forward.
PCI’s efforts demonstrate its capability as a flexible, turnkey partner, able to deliver both speed and precision in meeting urgent manufacturing needs. Shawn Cain, SVP Development and Manufacturing at PCI, emphasised the pride the team takes in supporting life-saving, orphan drug projects, underscoring the value of the partnership with ChiRhoClin.
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