AAI/CML has invested in significant upgrades to equipment and staff since acquiring the site in 2001, including a small-scale lyophilizer for cycle development studies conducted by a formulation development team on site. A second line for GMP batches was qualified in 2015 to support sterile manufacturing, more than doubling filling capacity. Recently, a new, mid-scale lyophilization unit has been installed and will be qualified by May, doubling the site's lyophilization capacity. The unit includes formulation development, fill/finish, packaging and testing for batch sizes up to 400L. Also, a third manufacturing shift has been added, increasing 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.