FinVector Aseptic Filling Capability
Aseptic Filling for Clinical Trial Supply and Commercial Gene Therapy Products
One of the key services FinVector offers is the aseptic filling of liquid investigational medicinal products (IMPs), or commercial products. This service is critical to support projects that require the supply of drug products for pre-clinical, Phase I, II and III clinical trials and for commercial use. This service operates from our manufacturing site in Finland, which is approved by the Finnish Medicines Agency (Fimea).
FinVector's aseptic filling services include:
- Flexible integrated processes to meet broad product requirements
- One automated filling suite (up to 2000 vials/hr) and two separate small-scale suites
- Aseptic product filtration in Sterile Single Use Systems within Grade A airflow cabinets, against a Grade B background
- Capability to undertake sampling/testing at critical stages during the process
- QP Release, supportive stability testing, GMP storage and distribution
- Full autoclave facilities for terminal sterilisation are also available.
Aseptic Fill Finish, 0.2micron product filtration
- Filling of 100ul-100ml into stoppered vials
- Batch sizes up to 10,000 vials/day automated fill or 10 – 300 vials controlled fill
- Compliant with US and EU regulations for commercial supply and clinical trial supply. Full project management oversight.
Clinical Labelling and Packaging
FinVector has a dynamic packaging process which enables us to provide bespoke labelling and packaging options based on client need. The process consists of vial surface decontamination, inspection, labelling, secondary packaging into an individual dose-protective pot, and freezing of the pack to below -60 ºC. This regime is highly adaptive and we have produced multi-vial variants for client labelling at their distributor of choice. Client-specific labelling can be applied to the vials for a range of self-adhesive label types.