How Novasep can address your clinical and commercial Fill & Finish needs
Around 80% of pharma & biopharma companies rely on CDMO (Contract Development and Manufacturing Organization) for the aseptic Fill & Finish (F&F) operations of their biologics*.
Indeed, expertise, experience and specific capabilities are key to achieve this critical and final step in the manufacturing process of biopharmaceutical products.
So if you are looking for a trusted CDMO partner for the sterile drug product manufacturing of your biologics, you’re not alone!
Discover now how Novasep can support your Fill & Finish clinical and commercial needs in this infographics!
A strong expertise in aseptic filling
- More than 20 years of experience
- 100% success rate for aseptic validation (MFT) over the past 3 years
Our know-how
- Viral vectors
- Live attenuated viruses
- Bacteria
- Plasmids
- mAbs (monoclonal antibodies) and recombinant proteins
- Other biologics
Therapeutic indication examples
- Cancer
- Ocular diseases
- Muscular diseases
- Hematologic diseases
- Prophylactic and therapeutic vaccines
- Central-nervous system (CNS) diseases
- Cell therapy / CAR-T intermediate products
Reliable process and flexible solutions
From your Drug Substance...
1. Thawing
2. Formulation
3. Filtration
4. Aseptic filling
5. Visual inspection
6. First labelling and packaging
7. Quality Control (QC) and release
...to your Drug Product
Flexible solutions
- Vial sizes: 2mL to 100mL
- Filled volume: 0,25mL to 100mL
- Glass or plastic vials: 100s to 1000s of vials
Our Fill & Finish capabilities
- 1 manufacturing site and 2 facilities in Seneffe, Belgium
- Clinical facility: semi-automatic or automatic filling, 100s to 4,000 vials per session
- Commercial facility, Senefill: automatic filling, multiple thousands of vials per session
#fillinggood
Want to learn more about our services, capabilities and technologies?
Download our brochure!
*Source: https://www.pharmoutsourcing.com/Featured-Articles/342564-Outsourcing-Trends-in-Biopharmaceutical-Manufacturing/
