Novasep - Contract Manufacturing Services for Synthetic Molecules and Biomolecules

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-industries markets.

Custom synthesis and purification of APIs

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

Our process development teams select, develop and optimise 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:

• Hazardous chemistry, including azide, diborane, diazomethane, nitroalkane, hydrazine, carbon disulfide and mercaptan chemistry, carbonylation, ozonolysis, sodium metal handling, cyclopropanation, oxidation with O2 and H2O2
• Asymmetric synthesis, chiral resolutions
• Highly potent API handling in our SafeBridge® certified facility
• Cryogenic chemistry
• Biocatalysis
• Process chromatography

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

Biopharmaceutical manufacturing

We master a large scope of upstream technologies:

• Microbial: E.coli, L.Lactis, yeast (including Pichia pastoris)
• Insect and mammalian cells
• Virus (retrovirus, parvovirus, alphavirus, influenza virus, lentivirus, etc.)
• Viral vectors
• Batch, fed-batch and perfusion modes
• Reusable and single-use systems

We excel in downstream technologies:

• Tangential flow filtration: microfiltration, ultrafiltration, nanofiltration
• Low, medium and high-pressure biochromatography
• Batch and continuous purification processes
• Solvent recycling
• Product conversion / reaction
• 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-scale cGMP lots

We manufacture cGMP lots from preclinical to commercial scale and also provide validation services and comprehensive regulatory support out of our three biomanufacturing facilities.

Complete manufacturing of antibody drug conjugates (ADCs)

We are one of the sole CMOs in the world able to provide a complete manufacturing solution for antibody drug conjugates (ADCs), from early development to commercial scale. MAb production is managed in our biomanufacturing facilities whereas the synthesis of the cytotoxic compound (payload), the mAb-payload conjugation and final purification is performed at our highly potent API dedicated site.

We have a unique organisation capable of designing your process, as well as engineering, building, validating and operating manufacturing plants for your biologics or synthetic APIs.

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 (various pre-formulation available), heptaminol, acefylline heptaminol, fenofibrate, sulpiride, tiapride hydrochloride, and metoclopramide hydrochloride.

In addition, we now offer complete development and manufacturing services for ADCs, including mAb production, cytotoxic agent synthesis, conjugation and downstream processing (DSP).