Novasep global solutions for the m More than a Contract Manufacturing Organization… We have developed a unique business model to meet the challenging manufacturing needs of the pharmaceutical, agrochemical, cosmetic and fine chemicals industries, from lab to industrial scale. Our solutions include: Process development services Exclusive synthesis and/or custom purification services Supply of chromatography equipment and systems Supply of proprietary products
… we are your partner of choice … Our extensive offering, expertise, flexibility as well as our commitment to confidentiality enable us to maintain long-standing and trusted relationships with our customers. We have professionnal and transparent project management practices, and we are happy to tailor the project communication to your needs.
Outsourcing Solutions Contract Manufacturing Services Exclusive Synthesis Contract Purification
Process Develo pme Chemical process devel Purification process devel
Our Tech nolo
Your Ne APIs & ADVANCED INTERMEDIATES
AGR
Products: Generic APIs
… when time and cost matter…
Special reagents and
Our solutions will help you reduce process development time while minimizing cost and the environmental impact of the manufacturing process. Our special chemical technologies allow a reduction in the number of chemical steps, thereby increasing yield. Furthermore, we have an efficient sourcing team and a network of reliable suppliers in Asia that we regularly audit, to access competitively priced starting materials and intermediates. Our expertise in combining chemistry with advanced purification technologies enables us to engineer and implement challenging product-specific processes in record time.
e manufacture of synthetic molecules … when flexibility is key… We can provide you with the appropriate solutions in the minimum amount of time. Given our staff’s know-how and our range of lab and manufacturing plants, we are able to simultaneously manage complex multi-step syntheses located across different sites to assist you in reducing the time-to-market for your molecule. We can also tailor the quality environment of our manufacturing process to the regulatory requirements of your application, from “made to spec” to full pharmaceutical cGMPs or other specific requirements.
velo pment Services cess development ocess development
Tech nologies
ur Needs AGROCHEMICAL INGREDIENTS & FINE CHEMICALS
ents and building blocks
In-sourcing Solutions Preparative Chromatography Systems HPLC
DAC Columns
SFC
Continuous Chromatography
… and when expertise is of utmost importance
We possess great expertise in high value, niche technologies. Over the years, we have gained unparalleled know-how in using extremely challenging chemistry and separation technologies at a very large scale. Our palette of technologies is unrivalled in its breadth and synergies. Using this palette, our 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.
Our unique palette of techn o Hazardous Chemistry Using hazardous chemistry steps generally helps to considerably reduce the number of synthesis steps as well as the amount of impurities and by-products generated ; leading to cost-effective syntheses affording the targeted compounds with higher yields and a lower environmental impact. We have more than 135 years experience in the production of hazardous compounds and in the identification of short and elegant synthetic routes using hazardous chemistry such as:
Azide Chemistry
Oxidation with O2 and H2O2
Ozonolysis
Hydrazine Chemistry
Diborane Chemistry
Carbon Disulfide & Mercaptans
Diazomethane Chemistry
Cyclopropanation
Carbonylation
Sodium Metal Handing
CHI
HAZARDOUS CHEMISTRY
HIGHLY POTENT APIs
Highly Potent APIs (HPAPIs) The manufacture of highly potent APIs requires high-containment manufacturing units as well as a high level of competence. Our Le Mans site is SafeBridge® certified; compounds with an Occupational Exposure Limit (OEL) less than 10 µg/m3 for 8 h (SafeBridge® category 3) and less than 0.03 µg/m3 for 8 h (SafeBridge® category 4) can be handled. Moreover, we have unique capabilities of combining synthesis with preparative chromatography in confined areas. Our offering for HPAPIs consists of:
Synthesis
Purification
Vectorization
We have great experience in HPAPI vectorization, including the synthesis of antibody drug conjugates (ADCs) and peptideconjugates. Since we can also manufacture monoclonal antibodies at Novasep Henogen, we are one of the sole companies worldwide able to provide total manufacturing solutions for ADCs.
AD
n ologies for synthetic molecules Chiral Chemistry We can identify and scale up the chiral technology that best suits your molecule in the minimum of time. The key chiral technologies we master include:
Asymmetric Synthesis
Preferential Crystallization
Chiral Chromatography
Diastereomeric Salt Formation
Enzymatic Resolution
Dynamic Kinetic Resolution
Chromatography and Membrane Technologies With more than 20 years’ experience in designing, building and using process-scale chromatography and membranes systems, we can help you identify the solution that best meets your purification challenges. Our main proprietary technologies include:
CHIRAL CHEMISTRY Preparative HPLC
TRY
Preparative SFC
CHROMATOGRAPHY & MEMBRANE TECHNOLOGIES
Continuous Chromatography SMB and Varicol® Ion Exchange Chromatography Membranes Filtration (UF, NF, RO) These technologies allow us to design and operate any chromatographic mode such as normal and reversed-phase, chiral, affinity, ion-exchange, etc.
ADVANCED ORGANIC SYNTHESIS
Advanced Organic Synthesis We possess extensive know-how and assets for conducting certain demanding reactions such as:
Cryogenic Reactions
Mitsunobu Reactions
Hydrogenation
Biocatalysis
Heterocyclic Chemistry
Transition Metal Catalysis
Friedel Craft Reactions
Organometallic Chemistry
Halogenation
And Many Others…
Novasep outsourcing solutions contract manufacturing services Process Development Services Our process development services address the challenge to quickly develop innovative, scalable and robust synthetic routes. We either scale up your chemistry or select, develop and optimize new synthetic routes and provide you with the appropriate solution to meet your regulatory, quality, quantity and timeline requirements. Our process development services include: Chemical route design
Process validation
Process optimization and scale-up
Analytical methods development and validation
Process safety
Custom Manufacturing Services We offer exclusive synthesis and custom purification services from kilogram to multi-ton scale. Our cost-effective and environmentally-friendly solutions can be scaled up or down in production to adjust to market demand. In addition, we can provide you with full regulatory support.
Capabilities 15 R&D Labs
Incl. chromatography and HPAPI Labs
From mL tests up to 15 L vessels (non cGMP)
4 multipurpose kilo labs and pilot plants
Up to 1,000 L reactors Temperature range from -80°C to 230°C Pressure range up to 10 bar
11 kilo labs and pilot plants (cGMP or non-cGMP) 2 kilo labs for HPAPIs 5 kilo labs for preparative chromatography
Up to 50 L reactors HPLC systems in confined area 10 HPLC, 2 SFC and 7 continuous chromatography (SMB/Varicol) systems Productivity from 10 to 2,500 g/day
12 multipurpose cGMP production suites
From 50 up to 25,000 L reactors Temperature range from -80°C to 230°C. Pressure range up to 10 bar
2 non-cGMP industrial units
Up to 12,500 L reactors Temperature range from -20°C to 150°C. Pressure range up to 6 bar
26 production suites (cGMP or non-cGMP) 9 production suites dedicated to industrial chromatography 3 production suites dedicated to HPAPIs
5 HPLC and 4 continuous chromatography (SMB/ Varicol) systems Productivity from 1 to 500 kg/day From 63 L to 1,200 L glass lined reactors HPLC systems in confined area
Novasep in-sourcing solutions and products Preparative Chromatography Systems As pioneers in preparative high performance chromatography, we guarantee the performance and robustness of both our systems and processes. We offer the broadest range of chromatography technologies to provide you with the best purification solution. We can supply you with HPLC, SFC, continuous chromatography systems equipped with Dynamic Axial Compression (DAC) columns, ranging from lab to industrial scale. Based on our experience and mastery of all these chromatographic technologies, we can help you identify the solution that best meets your purification challenges. High Performance Liquid Chromatography (HPLC)
Multicolumn Continuous Chromatography
Hipersep®
SMB/Varicol®
Supercritical Fluid Chromatography (SFC)
Dynamic Axial Compression Chromatography Columns
SupersepTM
Prochrom®
We offer you a full range of purification process development, expertise and customer service to support our purification technologies offering.
Fine Chemicals and Generic APIs We have developed and patented cost-effective and innovative manufacturing routes based on our proprietary technologies to produce several generic APIs (inc. Paclitaxel and Nitroglycerine) under full cGMP in our FDA-inspected facilities, and continue to develop new generic molecules based upon our chemical and purification strengths. Additionally, we market fine chemicals for the pharmaceutical, agrochemical and specialty chemical industries. They can help to perform specific reactions or simplify chemical routes. They are generally in stock or are promptly produced on order, optionally under full cGMP. Key families of chemicals available:
Boron compounds
Azides
Azodicarboxylic acid derivatives
Nitriles
Diazo compounds
Isocyanates
Triazoles & Tetrazoles
Nitro compounds
Organometallic compounds
For more information on the available compounds, please see our product catalogue.
