Aseptic filling is a critical step in the manufacturing process of biopharmaceutical products: high quality and 100% safety of the products are required for patients.
With a proven expertise, a strong track record and tried-and-true processes, Novasep offers clinical and commercial Fill & Finish (F&F) services for biologics, from formulation to packaging.
Fill & Finish expertise for biologics
Novasep’s team of experts has a long experience of providing Fill & Finish services for a wide range of biologics, including:
- Viral vectors: AAV, Adenovirus, Lentivirus, HSV, VEEV…
- Live attenuated viruses
- Monoclonal antibodies (mAbs), Fab, bispecific antibodies
- Recombinant proteins
- Natural extracts (plant-, animal-based)
The markets covered by our Fill & Finish services are various: cell & gene therapies, oncology, vaccination as well as other therapies.
Our Fill & Finish solutions
We offer a comprehensive set of services to meet your requirements for sterile filling:
- BSL1 and BSL2 products
- Semi-automatic or automatic liquid filling machine for more flexibility
- From hundreds to thousands vials per session
- Custom process and analytical development
- Custom process validation (sterile filters, volume, stoppers, vials…)
- Intermediate storage at various temperatures (RT, +4°C, -20°C, -80°C)
100% disposable materials
- Fully disposable filling system (tubing, needle and other assemblies)
- Ready-to-use vials (sterile and apyrogen)
Wide range of container closure configurations
- Vials type: 2mL to 100mL
- Filled volume: 0.25mL to 100mL
- Glass or plastic vials (CZ®)
Our integrated and reliable process for Fill & Finish
We offer a complete supply chain for drug product manufacturing:
Our Fill & Finish site in Belgium
Conveniently located on our manufacturing site, in Seneffe (Belgium), our Fill & Finish facility can support your clinical needs.
- 30 minutes from Charleroi (Belgium) airport
- 1 hour from Brussels (Belgium) or Lille (France) airports
Our ongoing investment in a new commercial Fill & Finish facility
To support the launch of your product, Novasep invests in a new commercial facility for aseptic Fill & Finish (F&F) operations: Senefill.
- A full state-of-the-art facility
- Automatic filling under isolator
- Up to 10 000 vials per session
- Filling of viral vectors, viruses, plasmids and other biologics (mAbs, proteins…)
- Commissioning in H2 2019
- Centralized QC laboratory
- Located in Seneffe, Belgium
Our clinical, commercial and QC capabilities for Fill & Finish will be on the same site for a seamless transfer.
Our Fill & Finish capabilities
Novasep has a wide range of capabilities adapted to viral vector manufacturing. To learn more, download our Fill & Finish brochure!