Your QC released bulk drug substance can be formulated to a specific concentration to include, if required, the addition of any non-active components or excipient in your specified solution. The formulated drug product pool is then aseptically filtered into a single use sterile filling assembly and aseptically filled using an automated tabletop filling machine. This operation occurs in an ISO 5 filling enclosure.
The filled vials are inspected for fill volume, container closure defects, and particulates. Finally, the vials are labeled and samples are submitted to Quality Control for release and stability testing.
VGXI offers the following in-house fill capabilities:
- Automated fills
- Validated filling operation
- High concentration plasmids up to 15 mg/mL
- Multi-plasmid formulations