Fill/Finish Capabilities for Complex Drug Products

 

Annex 1 Compliant Isolator Filling Lines 

Emergent has invested over $150M in three state-of-the-art isolator filling lines and complementary facility enhancements to meet the needs of our customers. These diverse, industry-leading aseptic fill/finish machines offer clinical and commercial manufacturing of vaccines and biotherapeutics. This strategic initiative was designed to provide additional manufacturing automation, more efficient turnaround times, expanded capacity, and to support your unique drug product manufacturing goals.

groninger® FlexPro 50 | Baltimore, MD​

The groninger® FlexPro 50 is a state-of-the-art fill/finish line that provides superior sterility with minimal line interventions and interruptions through the utilization of isolator-based technology.

  • RTU components: 2R and 10R ​
    • 1mL PFS​
  • Fully integrated, automated loading and unloading lyophilizer​
  • BDS up to 500L+​
  • Up to 100k units/batch​
  • Up to 2700 units/hr ​
  • In-process weight controls ​
  • VHP decontamination

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groninger® INTEGRA | Rockville, MD​

The groninger® INTEGRA is a high speed filling line for biologics, vaccines, and biosimilars. With an integrated SKAN isolator, this state-of-the-art technology is ideal for large-scale clinical and commercial projects. Within the same facility, we offer automated visual inspection and integrated packaging and labeling solutions.

  • Vial size range capability 2R to 100R​​
  • Batch sizes up to 160,000 vials (2R)​
  • 14,000 vials/hour (2R) fill rate​​
  • Late-stage and commercial products
​
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Cytiva SA25 | Winnipeg, Manitoba, Canada​

The world’s first gloveless, robotic filling isolator used to fill sterile, clinical and commercial products is available at the Emergent site in Winnipeg, Manitoba, Canada. Emergent was the first to acquire the SA25 and receive FDA and Health Canada approval. This state-of-the-art machine provides a high degree of sterility assurance for biopharmaceutical filling, minimal product loss, and with its flexible design base, is critical to support high value, small batch size medicines. 

  • RTU components and flow path​
    • Vials: 2R, 6R, 10R
      (20R, 30R, 50R - future)
  • Pre-filled syringes​
  • Minimal line loss​
  • Maintains sterility and compliance with minimized operator intervention​​
  • 12,600 vials/24 hours (2R) fill rate​
  • Peristaltic pump​
  • Capping in isolator
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