Novasep is a trustable and agile partner to drive your project to success. Over the years we have manufactured a large number of recombinant proteins using various expression platforms.
Expert in cell-culture and fermentation processes, we can produce your:
- Antigens from virus, bacteria or parasites
- Fusion proteins and conjugated proteins
- Enzymes and other metabolites (IFN, IL-10, etc.)
Unique capabilities and methodology
We offer the following range of services:
- Full process and technological transfer
- Upstream process development:
- Cell adaptation to serum-free, suspension growth
- Creation of Master Cell Bank (MCB) and Working Cell Bank (WCB)
- Optimization of cell culture and fermentation parameters (feeding strategy…)
- Conditions of expression induction optimization
- Lysis conditions optimization
- Downstream process development
- Clarification optimization
- Optimization of purification steps (filtration and chromatography operations)
- Virus inactivation conditions
- Process scale-up and validation
- Aseptic F&F for liquids in glass vials
- Full analytical transfer, development and qualification
Capacities and facilities
Our two sites in Belgium (Seneffe and Gosselies) are specialized in the production of recombinant proteins.
Process development labs and offices: 3,000 m²
Upstream and downstream cGMP suites: 900 m²
Dedicated area for hazardous biologics: 120m² QC labs: 300 m²
Up to 1,000 L for cGMP production
Up to 100 L for cGMP production
CHO, VERO, HEK, MRC-5, SP2/0, 3T3, MDCK, NS0, proprietary cell lines, etc.
|Bacteria and yeasts||
E.coli, Staphylococcus, Shigella, V.cholera, Lactococcus lactis,
|Insect cell lines||
SF9, SF21, Hi5, etc.
From 10 to 300 mm I.D.
TFF units for MF and UF/DF
Our track record
We have a rich and extensive experience in the cGMP production and purification of multiple recombinant or native proteins including:
- Large panel of viral proteins from HPV, VZV, CMV, EBV, HSV, etc.
- Parasites proteins (for example from Plasmodium, responsible of malaria)
- Lipo-polysccharides from V.cholerae, N.meningitidis, etc.
- Conjugated proteins with polysaccharides and fusion proteins
- Monoclonal antibodies and mAb fragments
- Hormones/cytokines & growth factors including IFN, IL-10, hTFF1, etc.
Our BSL2/BSL3 pathogens manufacturing facility, dedicated to contained production, can be proposed to manufacture hazardous biologics or compounds such as toxins and allergens. Learn more about our BSL3 pathogens manufacturing capabilities.