09.07.17
Alcami has unveiled plans for a Center of Excellence at its active pharmaceutical ingredient (API) development and manufacturing facility in Germantown, WI.
"The establishment of a Center of Excellence for API development, scale-up and commercialization in Germantown, coupled with our extensive regulatory expertise greatly strengthens the foundation of our business and allows innovators to execute all parts of API development and manufacturing in one U.S.-based location to support their launch," said Stephan Kutzer, chief executive officer, president and chairman, Alcami. "We are excited to expand our capabilities and fuel the growth and success of Alcami while simultaneously upholding the commitment to our customers to deliver seamless, efficient end-to-end small molecule services."
The company said demand for its end-to-end offering, which launched in March 2016, contributed significantly to the decision to expand. End-to-end projects represent 10 percent of its total business. Approximately 62 percent of those projects originate from 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," stated Ted Dolan, chief operating officer, Alcami. "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."
Previously announced capability extensions in Controlled Substances and Highly Potent API (HPAPI) will also be serviced by the Center of Excellence. In June of 2017, the company 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 state-of-the-art production suites equipped with engineering controls designed to meet the established Occupational Exposure Limit (OEL) of minimally 0.03 μg/m3 (SafeBridge Category 3). The company initiated process development for its first HPAPI program in Q2 2017 and will begin manufacturing in Q4 2017 with a pipeline of programs to follow.
"The establishment of a Center of Excellence for API development, scale-up and commercialization in Germantown, coupled with our extensive regulatory expertise greatly strengthens the foundation of our business and allows innovators to execute all parts of API development and manufacturing in one U.S.-based location to support their launch," said Stephan Kutzer, chief executive officer, president and chairman, Alcami. "We are excited to expand our capabilities and fuel the growth and success of Alcami while simultaneously upholding the commitment to our customers to deliver seamless, efficient end-to-end small molecule services."
The company said demand for its end-to-end offering, which launched in March 2016, contributed significantly to the decision to expand. End-to-end projects represent 10 percent of its total business. Approximately 62 percent of those projects originate from 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," stated Ted Dolan, chief operating officer, Alcami. "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."
Previously announced capability extensions in Controlled Substances and Highly Potent API (HPAPI) will also be serviced by the Center of Excellence. In June of 2017, the company 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 state-of-the-art production suites equipped with engineering controls designed to meet the established Occupational Exposure Limit (OEL) of minimally 0.03 μg/m3 (SafeBridge Category 3). The company initiated process development for its first HPAPI program in Q2 2017 and will begin manufacturing in Q4 2017 with a pipeline of programs to follow.
