Sterile Fill/Finish Manufacturing Capabilities & Expertise

Our 87,000 sq. ft. aseptic fill/finish US facility in Baltimore—home to two cutting-edge isolator-based filling lines is designed to support complex sterile injectable programs across clinical and commercial stages.
 
In addition to our advanced Groninger USA FlexPro 50 line, which supports high-speed, high-quality filling of vials, syringes, and cartridges with lyophilization capabilities, we’ve expanded our offering with the new AST GENiSYS® C automated filling line.
 
Operating under full isolator conditions, the GENiSYS® C is purpose-built for clinical and small-scale commercial supply, especially for high-value, high-complexity products. Together, these two filling lines allow us to flex between batch sizes, molecule types, and program stages—without compromising quality or sterility.
 

Facility Highlights:

  • Groninger FlexPro 50: robust, scalable filling with integrated lyophilizer
  • NEW AST GENiSYS® C: agile, isolator-based clinical & small-batch commercial filling
  • Full capabilities for vials, syringes, and cartridges
  • Support for biologics, mAbs, and other sterile injectables
  • End-to-end cGMP services: formulation, filling, inspection, packaging, and analytics
With flexibility built into our infrastructure, we’re ready to support your product’s journey-
from first-in-human to commercial launch.
 
Discover the benefits of utilizing isolator technology for your aseptic manufacturing program. 

Download Sterile Fill/Finish One Pager