Novasep - A Leading Partner for the Life Sciences Industries

Novasep develops, markets and operates innovative technologies to produce synthetic molecules and biomolecules from lab to industrial scale. Our applications cover the pharmaceutical, biopharmaceutical, functional ingredient, food ingredient and bio-industry markets.

Pharmaceutical and biopharmaceutical process development, outsourcing and in-sourcing

Our unique offering for pharmaceuticals and biopharmaceuticals comprises:

• Process development services (multi-step synthesis for APIs and advanced intermediates, purification of APIs, synthetic peptides and intermediates, and biopharmaceutical manufacturing from the cell to the vial)
• Outsourcing solutions (contract manufacturing of APIs, advanced intermediates and biopharmaceuticals)
• In-sourcing solutions biochromatography and TFF systems and products, purification processes with guaranteed performances, and reagents, building blocks and generic APIs

Custom synthesis and purification of APIs

Our process development teams select, develop and optimize synthetic routes to provide you with cost-effective solutions in the minimum amount of time (up to 400 chemical steps scaled-up each year). Novasep combines conventional chemistry with special technologies, including:

• Hazardous chemistry, including azide, diborane, diazomethane and hydrazine chemistry, carbonylation, ozonolysis
• Asymmetric synthesis and chiral resolutions
• Highly potent API handling in our SafeBridge® certified facility
• Cryogenic chemistry
• Biocatalysis
• Process chromatography

Batch and continuous chromatography processes

Novasep develops batch and continuous chromatography processes, based on its unique pool of proprietary technologies and computer modeling software.

Contract synthesis and purification

We offer contract synthesis and purification in six FDA-inspected facilities for early development, clinical and commercial scale (up to several hundred tons), with full regulatory support.

Antibody-drug conjugate development and manufacturing

We now offer complete development and manufacturing services for antibody-drug conjugates (ADC), including mAb production, cytotoxic agent synthesis, conjugation and downstream processing (DSP).

Biopharmaceutical manufacturing

We provide a large scope of upstream technologies including microbial (E.coli, L.Lactis and yeast [including pichia pastoris]; insect and mammalian cells; virus (retrovirus, parvovirus, alphavirus, influenza virus, lentivirus, etc.); viral vectors; batch, fed-batch and perfusion modes; and reusable and single-use systems.

We also excel in downstream technologies: tangential flow filtration (microfiltration, ultrafiltration and nanofiltration); low, medium and high-pressure bio-chromatography; batch and continuous purification processes; solvent recycling; product conversion/reaction; and reusable and single-use TFF cassettes and systems.

Our unique scope of development services includes cell banking (master and working cell banks), analytical transfer and validation, feasibility studies, process modelling, upstream and downstream process development (including formulation and fill and finish) and scale-up.

Preclinical to commercial cGMP lot manufacture

We manufacture cGMP lots from preclinical to commercial scale and also provide validation services and comprehensive regulatory support from our three bio-manufacturing facilities.

We have a unique organization capable of designing your process, as well as engineering, building, validating and operating a bio-manufacturing plant for your biologics.

Supply of chromatography and filtration systems

With more than 20 years' experience in designing, building and using preparative chromatography systems, Novasep offers:

• Prochrom® dynamic axial compression (DAC) HPLC columns, from 5cm to 2m id
• Hipersep® preparative and process scale HPLC skids
• Supersep™ Preparative SFC, for g/day to t/year applications
• Varicol® and SMB multicolumn continuous chromatography systems, for kg/day to 100t/year separations

Biopharmaceutical DSP products and technologies

We also offer a full range of high performance products and technologies for biopharmaceutical DSP:

• Prochrom® DAC bio-chromatography columns, from 10cm to 2m id, 5bar and 20bar
• Hipersep®-bio preparative and process scale bio-chromatography skids
• BioSC®, sequential multicolumn chromatography system for continuous capture
• AbSolute™, a revolutionary Protein A media for mAb and IgG capture
• Sius™, the first pre-sanitized, disposable TFF cassettes
• NovaSet™ reusable TFF membranes and filtration skids

Supply of special reagents, building blocks and generic APIs

Thanks to our unique palette of technologies, we have developed a number of reagents, building blocks and fine chemicals. Moreover, we can provide you with generic APIs produced under cGMP conditions at highly competitive prices, such as paclitaxel, nitroglycerin and heptaminol.