Covance doubles metabolite testing capacity

By Gareth Macdonald

- Last updated on GMT

Related tags: Clinical trial, Pharmaceutical industry, Pharmacology, Covance

US CRO Covance has expanded its preclinical development offering, doubling metabolite identification capacity at its facility in Madison, Wisconsin.

The firm now has a staff of 14 senior scientists dedicated to preclinical and early clinical metabolite identification, as well as five accurate mass spectrometers and six quadrupole linear ion trap (QTrap) spectrometers.

Covance said that the latest expansion is in response to both increasing customer demand and the recent US Food and Drug Administration (FDA) guidance on safety testing of drug metabolites.

A company spokesperson told Outsourcing-pharma that: "We view metabolite identification as an important component of both preclinical and clinical studies conducted at Covance.

He added that: "Going forward, we expect there to be continued emphasis by clients on following the recommendations set forth in the [FDA} Guidance to improve the safety of drug candidates and reduce development and marketing delays.​"

Covance believes that the extra capacity will help its drug development customers obtain pre-clinical results sooner, cutting the time taken to initiate trials and, ultimately, bring new products to market quicker.

Preclinical expansion programme

The expansion is the second that Covance has carried out in as many months. In June it doubled its capacity for long-term stability and release testing, significantly boosting its roster of chemistry, manufacturing and control (CMC) services.

Prior to that, in April, the New Jersey headquartered group opened a new $175m (€133m) preclinical testing laboratory in Chandler, Arizona further expanding its early phase safety and toxicology testing offering.

The focus on preclinical work is understandable given that, in common with most US CROs, Covance has suffered from a drop in orders for its clinical trial business as the pharma industry cuts development spending in the economic downturn.

Metabolite testing market hots up

Metabolite testing and identification has been the focus of much pharmaceutical industry attention of late as drugmakers seek to improve the efficiency of development spending and safety of new products.

This growing demand has seen a number of contract research organisations (CRO) ramp-up their offerings in the area, most recently Novacta Biosystems and UK group Cambridge Major Laboratories (CML) who teamed up in March.

At the time Novacta's CSO, Mike Dawson, said that “Novacta Biosystems goal is to be the premier service provider of biocatalysis and metabolite solutions and an alliance with such a high profile company is a great step forward.”

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