October 1, 2011 (Vol. 31, No. 17)
Innovative Manufacturing Solutions for the Life Science Industry
Novasep brings innovative solutions to complex challenges within the life science industry for the production of synthetic molecules and biomolecules from lab to industrial scale.
In order to fulfill our customers’ ingredient needs, we develop and use a broad portfolio of technologies to support our unique business model: we develop manufacturing solutions, we provide custom manufacturing services (out-sourcing solutions), we sell purification equipment and processes (in-sourcing solutions).
Our offering helps our customers enhance product quality, reduce production costs, and shorten time-to-market.
We operate through two complementary business divisions, Novasep Process and Novasep Synthesis.
Novasep Synthesis uses a large range of chemical synthesis and purification technologies to develop and produce high value-adding active ingredients and advanced intermediates for the pharmaceutical, crop science, and other fine chemical industries.
Novasep Process supplies innovative purification systems to the pharmaceutical and biopharmaceutical industries and provides contract manufacturing services for biopharmaceuticals.
About the Company
Novasep was created in 1995, building upon its great expertise in continuous chromatography and process-scale HPLC technologies. Novasep Process developed a comprehensive technology offering for biopharmaceutical downstream processing, including its complete range of low-pressure chromatography columns and systems, continuous biochromatography, and innovative tangential filtration technologies. Furthermore, Novasep Process offers global cGMP contract biomanufacturing services including USP, DSP, formulation, and fill and finish.
Novasep has developed, markets, and operates a broad portfolio of innovative technologies to supply global biomanufacturing solutions to its customers. We work from our customers’ process or develop one from scratch, always sharing with them the know-how, vision, and realistic expectations. Our difference relies on the integration of our advanced technologies into bioprocessing and our strong process-development capabilities. Then, depending on the customers’ manufacturing strategy, they are free to choose between in-sourcing our downstream processing technologies or outsourcing production with us…or both!
Novasep Process’ unique offering is applicable to most biologicals such as mAbs, antibody-drug conjugates (ADCs), recombinant proteins, peptides, recombinant subunit vaccines, live attenuated vaccines, viral vectors; toxins, adjuvants, blood proteins, oligosaccharides, transgenic biomass, and hormones.
In particular, our customers trust us because we master a broad range of technologies for upstream processing (microbial, yeast, insect cells, mammalian cells, viruses, viral vectors) in batch, fed-batch, and perfusion modes; reusable or single-use systems; as well as for the downstream processing: low, medium, and high pressure chromatography; batch and continuous purification processes; solvent recycling; reusable or single-use TFF systems.
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.
81 Boulevard de la Moselle
54340 Pompey, France
Phone +33 3 83 49 71 00
Date Founded 1995
Number of Employees 1,200