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Good manufacturing practices (GMP) are not limited to drugs that are approved to market by the FDA. GMP guidance also applies to investigational drugs that are still undergoing clinical trials. Manufacturing clinical trial material means having a keen understanding of current GMP requirements to ensure drugs are produced consistently with strict quality controls in place, but there are some unique challenges at play that aren’t present during later stages of drug development. Here’s what you need to know about GMP in clinical research.
Our clinical manufacturing facility is located in North Brunswick, NJ, and features Class 10,000 (ISO 7) and Class 100 (ISO 5) cleanrooms for the cGMP manufacture of sterile injectables and Class 10,000 (ISO 7) manufacturing suites for oral dosage forms. We can provide clinical trial batch manufacturing for phase I and phase II materials, whether they’ve been formulated by our team or formulated elsewhere and transferred to Ascendia.
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