Alcami Corporation, a provider of custom manufacturing and development services for the pharmaceutical and biotechnology industries, has announced additional laboratory-scale capabilities to support prefilled syringes in Wilmington, NC and the successful completion of previously announced investments in Charleston, SC.
Alcami has invested in state of the art, semi-automated vacuum stopper equipment in Wilmington, NC, to generate prefilled syringe samples that can be used to screen & select components, complete compatibility studies, and conduct developmental stability studies. With this equipment, Alcami can generate bench/pilot scale representative samples, minimizing the amount of Active Pharmaceutical Ingredient (API) required to generate this critical data.
Additionally, their clinical and commercial manufacturing facility in Charleston, SC has successfully produced clinical supply from its recently qualified second line with commercial manufacturing to follow. Coupled with the existing fill line, the site has doubled its filling capacity in 2016. A new, mid-scale lyophilization unit is being qualified, doubling the site's lyophilization capacity. To complement the additional equipment capacity, a third shift has been created, further adding capacity and scheduling flexibility with operations running 24 hours a day, five days a week.
"It is exciting to see the successful completion of recent investments that have enabled the doubling of our filling and lyophilization capacity at our Charleston site, and the extension of our development capabilities into pre-filled syringes. The site has introduced 17 new programs this year and is geared to support increasing demand within the Pharma & Biotech industry for sterile drug product development and manufacturing," stated Ted Dolan, Chief Operating Officer.
The Charleston, SC facility recently completed an FDA General Inspection that resulted in zero 483 observations as well as a successful EMA inspection supporting multiple commercial products. These results demonstrate Alcami's ongoing commitment to quality and regulatory compliance. Alcami's sterile manufacturing facility has a long-standing track record of compliance supporting numerous clinical and commercial regulatory filings globally.