Our mission is to bring process and product innovation to bioprocessing to support our customers in the development of their biomolecules from preclinical to commercial batches in the most efficient way.
Novasep’ solutions include bioprocess development and contract manufacturing services from master cell bank to the commercial released drug product, including aseptic formulation and fill and finish.
We are able to provide turnkey services from gene to clinical product, including cell or virus banking; USP-DSP development; scale-up; formulation and fill and finish; QC development, validation and final release for clinical trials.
Within our three production sites, we offer state-of-the art facilities with 1,000 m2 of process development laboratories, 2,500 m2 of cGMP suites including 1,800 m2 of class C cleanrooms and 3 class A aseptic filling suites, multiple DSP suites (4°C, 22°C), 10 BSL2 and 3 BSL3 suites for virus and pathogen production, 800 m2 of QC laboratories; we use a full range of equipment including: stainless steel or disposable bioreactors and fermentors from 3 L to 1,000 L, multiple biochromatography and TFF systems, and an explosion proof (ATEX) area, for processes requiring organic solvents.
Novasep pilot- and industrial-scale biochromatography solutions include: Prochrom® low, medium, and high pressure chromatography columns of up to 1.6 m i.d. and automated systems with PAT-based in-line dilution capabilities; BioSCTM sequential multicolumn chromatography systems for the most cost-effective capture of biologics including mAbs; AbSolute®, a novel silica-based Protein A media for high-velocity mAb capture.
Novasep also offers a broad range of tangential flow filtration (TFF) solutions, from lab to industrial scale, such as NovasetTM reusable polymeric cassettes and holders, and SiusTM, high-performance disposable TFF cassettes, which combined with SiusTM disposable filter plate insert, constitute a complete, presanitized disposable TFF unit compatible with any existing holders.