AAIPharma Services Corp./Cambridge Major Laboratories, Inc. (AAI/CML), a provider of custom manufacturing and development services for the pharmaceutical and biotechnology industries,has expanded sterile fill-finish capabilities and capacity in its Charleston, South Carolina site.

When AAI/CML acquired the Charleston facility in 2001, it had one filling line with small-scale lyophilization. The site has invested in 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. 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.

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.

Source: AAI/CML