A Closer Look at Small-Scale Kilo Labs & API Operations
One of the linchpins in AMRI’s global network of facilities is its combination of small-scale current good manufacturing practice (cGMP) kilo labs, along with its large-scale active pharmaceutical ingredient (API) manufacturing site. The small-scale cGMP kilo labs are co-located with Chemical Development at the Albany headquarters campus. These kilo labs provide the first scale-up of processes that come out of the Chemical Development group and serve as the conduit for further process scale up at AMRI’s large-scale manufacturing API site in Rensselaer.
Small-Scale cGMP Manufacturing
The small-scale cGMP manufacturing process includes:
- Eight separate and fully dedicated cGMP kilo suites with a total production area of ~6,000 square feet.
- Suitability for API production at clinical Phase I, II and III.
- The ability to produce small gram to 10-kg batch scales.
- A flexible mixture of 22–200 L Hastelloy and glass-jacketed reactor systems.
The large-scale API manufacturing Rensselaer site has been the home to various companies over the years and was initially founded by Bayer over 100 years ago. It was the first U.S. site to manufacture aspirin. In the last 15 or more years, AMRI, as well as the site’s previous owners, have invested tens of millions of dollars to upgrade, modernize and add capacity.
“We have everything needed to produce quality APIs safely at this 23-acre site,” says Richard Saffee, general manager of operations at the Rensselaer site, “but on top of that, we are able to draw upon the experience of our colleagues from anywhere in the world.”
Please tune into tomorrow’s Chemical Equipment Daily for part four of this five-part series. To read part one of this four-part series, please click here. To read part two of this four-part series, please click here.