AAI/CML expand capabilities and capacity for sterile drug product manufacturing

Charleston site in South Carolina installs second GMP line and increased lyophilisation capacity

US-based custom manufacturing and development services company AAIPharma Services/Cambridge Major Laboratories (AAI/CML) has expanded sterile fill-finish capabilities and capacity at its Charleston, SC site in response to substantial growth in demand.

When AAI/CML acquired the Charleston facility in 2001 it had one filling line with small-scale lyophilisation. The site has invested in significant upgrades to equipment and staff since, including a small scale lyophiliser for cycle development studies conducted by an expert formulation development (FDL) team on site. Customers requiring lyophilisation 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 lyophilisation unit has been recently installed and will be qualified by May, doubling the site's lyophilisation 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 specialised areas of drug product development and manufacturing,' said Ted Dolan, Chief Operating Officer.

The additional lyophilisation unit extends AAI/CML's integrated service offerings, which include formulation development, fill/finish, packaging and testing for batch sizes up to 400L.

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