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Contract manufacturing for monoclonal antibodies and mAb fragments

Contract manufacturing for monoclonal antibodies and mAb fragments

Novasep banner monoclonal antibodies development and manufacturing 3

We offer full contract manufacturing services for monoclonal antibodies (mAbs) production including upstream processing (USP) and downstream processing (DSP).

By combining our process development methodology and our technological innovations for mAb purification such as our BioSC® multicolumn sequential chromatography, your process will be smarter and each gram of mAb will cost you less.

From process development to cGMP manufacturing

Our capabilities include:

  • Analytical transfer, development and qualification
  • Cell line development and selection (through partnership)
  • Upstream process development:
    • Production of Master Cell Bank (MCB) and Working Cell Bank (WCB)
    • Optimization of cell culture parameters (feeding strategy, harvest time…)
    • Clarification optimization
  • Downstream process development
    • Development of purification process (batch vs continuous chromatography, TFF membranes, etc.)
    • Optimization of each purification step individually
    • Optimization of the whole purification process to minimize hold times and costs
    • Definition of the virus removal strategy and conditions
    • UF/DF, formulation
  • Non-cGMP production (demo/tox batches)
  • cGMP production of your mAb or mAb fragment
  • Process scale-up and validation
  • Stability studies

Our capacities and facilities for monoclonal antibody manufacturing

Novasep Cell Culture 300L BioreactorTwo sites are specialized in the production of mAb, in Belgium near Brussels: Seneffe and Gosselies.

Process development labs and offices: 3,000 m² 
Upstream and downstream cGMP suites: 900 m²
QC labs: 300 m²


Upstream Processing

Bioreactors Single-use and stainless steel
From 3 to 1,000 L
Expression systems CHO, HEK, proprietary cell lines, etc.
Cultivation process Batch, fed-batch, perfusion (ATF)


Downstream Processing

Chromatography Continuous chromatography system: BioSC®
Batch chromatography from 10-300 mm I.D.
Filtration Multiple TFF units for MF and UF/DF
Bioburden reduction
Viruses removal

Our track record

We have built a track record in monoclonal antibodies manufacturing including anti-CDX (anti-CD3, anti-CD7…), anti-rhesus, IgG1, IgG2 and mAb fragments ScFv or fusion proteins with various IgGs.

If you are producing antibody-drug conjugates, we can propose you, beyond the mAb production, a dedicated ADC manufacturing service including payload and linker manufacturing.

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