AAIPharma Services/Cambridge Major Laboratories expands capabilities and capacity for sterile drug product manufacturing in Charleston, SC

When AAI/CML acquired the Charleston facility in 2001 it had one filling line with small-scale lyophilization. The site has invested in significant upgrades to equipment and staff since, including a small scale lyophilizer for cycle development studies conducted by an expert formulation development (FDL) team on site. Customers requiring lyophilization receive the benefits of quick turnaround times from an experienced staff that also supports sterile filling and GMP manufacturing.

A second line for GMP batches was qualified in 2015 to support continued growth in demand for sterile manufacturing, more than doubling the filling capacity for the site. This has been used for multiple regulatory submissions and is expected to produce its first commercial product in 2016. A new, mid-scale lyophilization unit has been recently installed and will be qualified by May, doubling the site's lyophilization capacity. To complement the additional equipment capacity, a third manufacturing shift has been added, increasing capacity and scheduling flexibility.

"These upgrades to our manufacturing facility in Charleston support the overall progress of our growth as a company to meet the needs of our customers. We are excited to offer increased sterile manufacturing capacity to the market and added capabilities for specialized areas of drug product development and manufacturing," stated Ted Dolan, Chief Operating Officer.

The sterile manufacturing facility has an excellent track record of compliance and has been referenced in 15 regulatory filings. The additional lyophilization unit extends AAI/CML's integrated service offerings, which include formulation development, fill/finish, packaging and testing for batch sizes up to 400 L.