Downstream Biomanufacturing Services
An expert manufacturing partner for your biologics production.
Contracting the purification of your biologics with Novasep – your benefits
A unique set of expertise at your service
With Novasep, you benefit from our unique expertise acquired by our teams in both designing and using our innovative biochromatography and tangential flow technologies. As part of our global outsourcing solution, we ensure a smooth transfer of the process package from pilot/clinical production to our commercial biomanufacturing plant.
A time-efficient and cost-effective proposition from plant engineering to validation
Biopharmaceutical production processes always require specific equipment, process layout, and sometimes the building of a specific plant. As an example, within 24 months, we successfully performed the fast-track engineering and construction of our biomanufacturing plant in Pompey, France; a 20 M€ facility equipped with 900 m2 class C clean rooms for complex biopharmaceutical downstream processing.
A versatile track record
Through many projects, we have performed downstream processing such as :
- purification of monoclonal antibodies up to 750 g,
- inclusion body up to 100 L,
- human plasma up to 20 L,
- haemoglobin up to 100 L,
- vaccines up to 200 L,
- viral vector at 48CF10
- recombinant proteins up to 10 kg/year
- vaccine adjuvants : multi-kilo scale workshop
Downstream Manufacturing Services – Our Offering
A large range of technologies and know-how
Novasep is an experienced partner who is both an end-user and provider of purification technologies:
- TFF: microfiltration, ultrafiltration, nanofiltration
- Low, medium and high pressure chromatography
- Batch and continuous purification processes
- Solvent recycling
- Reusable or single-use systems
- cGMP custom purification operational since 2002:
- AFFSAPS-inspected in May 2005
- FDA-inspected (PAI) in September 2005 - no 483 issued
- One multi-purpose, explosion proof (ATEX) facility of 1000 m2.The plant has controlled areas and 4 separated, fully contained,automated purification lines (batch & continuous chromatography) with solvent recycling capabilities.
- One facility of 900 m2 class C, 1500 m2 controlled area, able to handle both water-based biomanufacturing processes and solvent based unit operations, with a dedicated explosion proof solvent storage area. This facility includes a pre-equipped 1,500 m2 area for implementing future biomanufacturing processes.
- Several areas pre-approved for future pharmaceutical and biopharmaceutical manufacturing, to guarantee the fast implementation of future bioproductions.
To discover our site in Pompey, France : click here.
Download our brochures for biologics manufacturing.
For any question on Novasep's manufacturing services and equipment for biologics, please contact us.