Alcami to Establish API Center of Excellence

On Sep. 6, 2017, Alcami, a custom development and manufacturing service provider for the pharmaceutical and biotechnology industries, announced the development of a Center of Excellence at its API development and manufacturing facility in Germantown, WI.

The center’s formation is a response to the need for improvement in the company’s ability to deliver end-to-end small molecule services and will allow for the execution of all parts of API development and manufacturing in one domestic location. Since the program’s inception, end-to-end offerings have made up 10% of the company’s total business, with 62% of those projects conducted at the Germantown site.  

“The Germantown API Center of Excellence will provide an exceptional platform to further advance our differentiating approach to control strategy at each phase of the development process through a series of investments targeted at infrastructure, work force, tools and technology,” said COO Ted Dolan, in a company press release. “Upon completion, the Center of Excellence will provide a comprehensive single service source for clients seeking to accelerate drug substance and product development, quantify and manage risk, design, scale-up and commercialize manufacturing processes designed for quality.”

Additionally, previously announced capability extensions in controlled substances and highly potent API (HPAPI) will be serviced by the center. In June 2017, the company also received Drug Enforcement Agency (DEA) bulk manufacturer registration to complement its previous analytical and researcher registration. HPAPI capability implementation is in its final phase with two cGMP production suites equipped with engineering controls designed to meet the established occupational exposure limit of minimally 0.03 μg/m3. The company initiated process development for its first HPAPI program in the second quarter of 2017 and will begin manufacturing in the fourth quarter of 2017, with a pipeline of programs to follow.

Source: Alcami