Laboratory Corporation of America Holdings (LabCorp), the world's leading healthcare diagnostics company, announced that Covance Drug Development will open a cGMP-compliant pharmacy at its clinical research unit in Madison, Wisconsin, allowing for on-site production of high-quality, customized pharmaceutical products for clinical trials.
Covance, which opened its first cGMP pharmacy at its Dallas, Texas facility earlier this year, is the only CRO to implement cGMP standards for phase I manufacturing of investigational drug products in a US phase I clinical research unit. The Madison cGMP pharmacy will be available for client audits beginning in October.
Small-scale cGMP manufacturing meets the highest regulatory and safety standards and lowers the cost to manufacture pharmaceutical products for clinical trials. Covance's innovative facilities offer certified clean rooms that support a full range of sterile manufacturing, including aseptically prepared sterile parenteral investigative drugs and radiolabelled doses, as well as non-sterile investigational drug products.
"With dedicated pharmacists, production teams, and direct cGMP quality assurance oversight, Covance provides industry-leading quality and cost-effective manufacturing services with greater flexibility to help clients meet their phase I clinical trial needs," said Dr. Herman Scholtz, vice president & general manager, Early Clinical Services.
"These new drug development solutions demonstrate our commitment to providing innovative and differentiated solutions to streamline and enhance clinical trials, bringing innovative medicines to patients faster, and helping change the way care is provided."