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Fill & Finish: a reliable CDMO partner for sterile drug product manufacturing
Biopharmaceuticals

Fill & Finish: a reliable CDMO partner for sterile drug product manufacturing

Novasep banner: Fill & Finish services for biologics

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:

 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:

Aseptic 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:Novasep integrated process for Fill Finish services

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

Location of Novasep Fill and Finish site in Belgium

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) operationsSenefill.

  • 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!

Novasep Fill Finish Manufacturing Capabilities

 

Downloads
  • Fill and Finish services for small volume biologics
    Fill and Finish services for small volume biologics
    Aseptic filling is a critical step in the manufacturing of biopharmaceuticals products: discover our...
    Download +
  • A full range of services for your mAb
    A full range of services for your mAb
    Discover our full range of CDMO services for your monoclonal antibody from cell line development to ...
    Download +
  • Viral Vectors: finding the good in everyone
    Viral Vectors: finding the good in everyone
    Novasep is a reliable partner to support your clinical and commercial manufacture of viral vectors
    Download +
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