Short-run drug manufacture at the Clinical Research Unit (CRU) saved the sponsor around $200,000 and 9-12 months on its timeline.

1. HELPING A SMALL
BIOTECH REACH A
CRITICAL MILESTONE
How cGMP Manufacture in the Clinical Research
Unit (CRU) Stretched One Client’s Resources
A small biotechnology company approached Covance regarding its anti-edema therapy for patients affected by
disabling and life-threatening ischemic stroke. This sponsor had limited resources for development and needed to
reach a critical milestone for continued investor participation. The project was on clinical hold, as the FDA requested
further information about the drug manufacture. The sponsor’s goal was to manufacture the drug economically, then
retest and provide data to meet an aggressive timeline. Once the regulatory hold was lifted, the client could pursue
next-phase investment.
Understanding the Challenge
High-risk, high-stakes molecule development
Fast turnaround to meet the timeline
Cost efficiency to meet the budget
Solution: cGMP Drug Manufacture at the Clinical Pharmacy
Covance provided regulatory support to interpret the FDA’s requirements and ensure the necessary data would be collected
so that the clinical hold could be removed. This regulatory assistance is crucial for small biotechs, as most do not have
in-house regulatory expertise.
The Covance clinical pharmacology team proposed a short-run drug manufacture at the Dallas CRU, providing
documented quality to ensure patient safety while saving time and money. The team manufactured the drug to the
sponsor’s quality specifications and conducted the retest to gather the required clinical data – in only four weeks.
cGMP drug manufacture at the clinic used less of the sponsor’s valuable
active pharmaceutical ingredient (API) and avoided an expensive, lengthy
run at a contract development and manufacturing organization (CDMO).
The sponsor saved around $200,000 and 9-12 months on its timeline.
The next step was microbiology testing to validate samples. When the first vendor struggled with the process, Covance
recommended a different Covance-qualified vendor, which solved the problem in two short weeks. Nimble response,
strong relationships and vendor management expertise saved the day.
The sponsor conveyed that effective communication and project management greatly contributed to this project’s success.
Covance provided high responsiveness, reliable data and support for the sponsor’s interaction with investors to keep the
project alive and move it to a Phase I first-in-human (FIH) study with dose escalation.
Covance Inc., headquartered in Princeton, NJ, USA, is the drug development business of Laboratory
Corporation of America Holdings (LabCorp). COVANCE is a registered trademark and the
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