CMO expands API capacity in U.S.

This week marks the dedication of a large-scale active pharmaceutical ingredient manufacturing facility in Germantown, WI, by contract manufacturer Cambridge Major Laboratories. The company intends the facility, comprising six GMP suites capable of producing multi-ton quantities of APIs and advanced pharmaceutical intermediates, to be a high-quality, US-based supply option. Its construction became necessary as the company outstripped capacity at three sites--two in Germantown and another in the Netherlands, for an overall capacity of 400 manufacturing projects per year.

According to Brian Scanlon, chief business officer, Cambridge Major "wanted a homegrown facility, nearby for our control over it and for supply chain purposes, with no questions about quality. We didn't consider an offshore location."

The company plans to produce small molecule and general chemical substances--a combination of newly launched commercial APIs and some clinical APIs--in hopes of retaining the clinical business should those substances advance through the NDA stage. Current plans involve no highly toxic or cytotoxic substances.

Installed capacity totals 18,000 gallons (70 cubic meters), with expansion capability of 30,000 gallons (120 cubic meters). Thermal oxidizer technology aids in compliance with air quality standards. A large-volume tank farm yields efficiency in the use of solvents, according to the company.

FDA inspection of the facility is planned for the first half of 2009; the Germantown campus is already FDA-approved, Scanlon says.

- here's the announcement


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.