Novasep develops, markets and operates innovative technologies to produce synthetic molecules and biomolecules from lab to industrial scale.
We have developed a unique business model to meet the challenging manufacturing needs of the pharmaceutical, agrochemical, cosmetic, and fine chemicals industries for producing synthetic molecules. Novasep Synthesis’ solutions include:
• Process development services: multi-step synthesis and/or purification
• Exclusive synthesis and/or custom purification services, for your outsourcing needs, from preclinical to commercial scale, in our 6 FDA inspected facilities
• Supply of proprietary products, including reagents, building blocks and generic APIs
• Supply of chromatography equipment and systems, to insource the production of your active molecules
In addition, our knowledge in regulatory affairs will provide you with an efficient strategy for EU and US DMF filings or CMC drafting to ensure fast registration of your API.
Our unique palette of technologies
We possess great expertise in high value, niche technologies. Over the years, we have gained unparalleled know-how in using extremely challenging chemistry at a very large scale. This experience together with our specific capabilities constitutes a unique palette of technologies, unrivalled in its breadth and synergy. The key technologies we master include:
• Chiral technologies:
Asymmetric synthesis: diastereoselective synthesis, asymmetric catalysis, other enantioselective reactions.
Chiral resolution: chiral chromatography, enzymatic resolution, kinetic and dynamic kinetic resolution, preferential crystallization, diastereomeric salt formation.
Synthesis from chiral pool
• Hazardous chemistry:
Azide, diborane, diazomethane, hydrazine, carbon disulfide, and nitroalkane chemistry.
Ozonolysis, carbonylation, cyclopropanation, O2 oxidation, H2O2 oxidation, sodium metal handling.
• Highly potent active pharmaceutical ingredients (HPAPI):
Total synthesis, semi-synthesis, extraction, purification and vectorization, in our specialized, FDA-inspected and SafeBridge® certified facility.
• Advanced organic synthesis:
Biocatalysis, cryogenic reactions, Friedel-Craft reactions, micro-reaction technologies, transition metal catalysis, organometallic chemistry, hydrogenation, halogenation, heterocyclic chemistry, Mitsunobu reactions, semi-synthesis.
• Preparative chromatography:
High performance liquid chromatography, supercritical fluid chromatography, multi-column continuous chromatography (Varicol®, simulated moving bed), medium and low pressure chromatography.
• Purification and isolation technologies:
Membrane filtration (nano-, ultra-, micro-filtration), distillation
Crystallization and polymorphism control, spray drying
Based on this palette, our team of chemists and process engineers mix their talents and creativity to select the best combination of technologies to provide you with the most time-efficient, cost-effective, robust and environmentally friendly manufacturing process.
Moreover, we are the sole company able to offer solutions combining advanced chemical reactions with complex purification steps. The strong symbiosis between Novasep Synthesis and Novasep Process support our ability to design, produce and implement challenging purification processes, adapted to the specific needs of your synthesis, in record time.
Custom synthesis and purification offering
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. In addition, we develop batch and continuous chromatography processes, based on Novasep’s unique pool of proprietary technologies, including computer modeling software.
Our special chemical and purification technologies often enable us to reduce the number of chemical steps, thereby increasing yield and lowering the overall synthesis cost and time.
We offer contract synthesis and purification in 6 FDA-inspected facilities for development and commercial scale (from kilogram to multi-ton scale), with full regulatory support. Our reactors range from 1 L to 25 m3, for a total reactor volume of 940 m3, including 740 m3 of cGMP capacity This enables us to offer fast-track, multi-site syntheses for convergent or long syntheses, and dual-site out-sourcing strategies for very large volume projects or to address your security of supply concerns.
New! Through the integration of Novasep Process’ complete biomanufacturing solutions with our extensive highly potent compounds synthesis and purification, we now offer complete development and manufacturing services for antibody-drug conjugates (ADC), including mAb production, cytotoxic agent synthesis, conjugation and downstream processing (DSP).
Supply of chromatography and filtration systems
We have more than 20 years experience in designing, building and using preparative chromatography systems. Our Prochrom® line of equipment includes:
• Dynamic Axial Compression (DAC) columns HPLC columns, from 5 cm to 1.6 m i.d,
• Hipersep preparative and process scale HPLC skids,
• Supersep Preparative SFC, for g/day to ton/year applications,
• Varicol and SMB multicolumn continuous chromatography systems, for kg/day to 100 tons/year separations.
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, especially: tetrazoles, triazoles, azides, isocyanates, nitriles, nitro compounds, diazo compounds, azodicarboxylic acid derivatives, boron compounds, and organomagnesium compounds.
Moreover, we can provide you with generic APIs produced under cGMP conditions at highly competitive prices, such as Paclitaxel, Nitroglycerin and Heptaminol.
Send an inquiry on 1-ethyl-tetrazolinone to Dynamit Nobel GmbH Explosivstoff- u Systemtechnik (Novasep)
