Aseptic Fill Finish

Viral Vector & Protein Products

With aseptic filling operations in the U.S. and Europe, ABL provides our clients with the scheduling and logistical responsiveness needed to support global trials. Whether as part of a comprehensive development and GMP production program or to address drug product filling on a stand-alone basis, we integrate vialing, inspection, labeling, testing, and storage and distribution activities to meet the often demanding timelines for the provision of clinical trial materials.

ABL provides aseptic drug fill / finish for viral vectors and protein products using a fully automated Flexicon FPC50W filling machine installed within a Grade A Restricted Access barrier (RABS) system. The fill system can accommodate vial sizes ranging from 2mL to 100mL, where 2mL and 5mL have been fully qualified and are considered standard. A bracket approach is applied across the qualified fill configurations to a maximum lot size of 3000 vials, where one configuration of each size / component material of construction is re-qualified every six months.​

Standard fill capabilities:

  • In-line weight checks on every vial, reported in the lot summary for every product fill
  • Line speed ranging from 9 vials per minute to 20 vials per minute, depending upon fill configuration
  • Ambient temperature fills
  • VHP room changeover post-fill
  • Standard Type 1 Glass vials in 2mL and 5mL size with rubber stoppers and tear off aluminum seals
  • Standard Crystal Zenith vials in 2mL and 5mL size with rubber stoppers and tear off aluminum seals
  • Fill volume ranges from 0.5 mL in 2mL vials, to 4.8 mL in 5mL vials
  • 100% independent vial inspection performed by Quality Control
  • AQL Inspection
  • Labeling, packaging and shipping

Interested in knowing more about our fill finish services?