Novasep Synthesis sites: Le Mans site

Le Mans Site

HPAIs Synthesis and Purification

Novasep Synthesis in Le Mans, France, has a twenty year track record of success in highly potent multipurpose chemistry and purification by preparative chromatography.

One significiant example is its leadership in the synthesis and purification of Taxanes, among other molecules.

It is also a leading developer and producer of a range of HPAIs, such as Cytotoxics (Paclitaxel).

Expertise

Novasep Synthesis, Le Mans offers:

• early-stage up to industrial custom manufacturing services mainly focused on cytotoxics and highly potent products (HPAI).

• access to a wide range of technologies in its FDA's inspected facility.
• combine techniques such as extraction, synthesis and semi-synthesis, preparative chromatography, crystallization and containments for HPAI up to OEB 5, at any scale.

Services Process development, scale-up and validation Production of preclinical and clinical batches (cGMP or not) Industrial production for NDA or ANDA approved API, over several years. Development of analytical methods development and validation Stability Studies Regulatory expertise DMF filling

Site description

Novasep site in Le Mans is located in the close vicinity of the Le Mans University on a 20,000 m² site.
It includes:

• 3,000 m² of production areas
• 1,000 m² of laboratories (including Process and Product Development, Quality Control and labs)

Equipment

3 Kilolabs and 3 Industrial Suites Double jacketed glass reactors from 1 to 1000 litres (-60°C to 120°C) Batch evaporators (20 to 50 l.) and large scale falling film evaporators Automated preparative HPLC's (i.d. 50 to 450 mm) Filter-dryer 0,03 m2 to 0,17m2 with associated glove-boxes (Air Cleanliness Class 10,000) Confined spin dryers (up to i.d. 500mm) Tray dryers from 130 to 375 litres with associated gloves boxes (Air Cleanliness Class 10,000) Lab. scale freeze dryer

Analytical resources HPLC, GC, KF, IRFT, UV, DSC, LC-MS, LC-MS/MS, AAS NMR, XRPD

Special Safety Skills

• Ability to handle a broad range of highly potent chemicals
• Specific installations & equipment to operate processes using Highly Potent chemicals
• Toxicology and Industrial Hygiene management system
• Containment under OEB 5
• Extensive safety testing and training

In Le Mans' facility, the highly potent handling constraints are embedded into the culture, the behaviours, processes, personal regular trainings, in order to make Novasep Synthesis, Le Mans, a cutting-edge company handling highly potent molecules, respectful of environment and industrial hygiene.

Contact us

Novasep Le Mans site (Séripharm) Rue Démocrite 72000 Le Mans FRANCE seripharm@novasep.com

Phone: +33 243 39 94 40 Fax: +33 243 39 94 49

Access to Novasep Le Mans site:

By car:

take exit 8 on highway A11. Turn left on road N157 and proceed about 3 km. At the roundabout, turn left onto Rue Bartholdi and then right onto Rue Héraclite.

By train:

Novasep Le Mans site (Séripharm) is also easily reachable with non stop TGV connexion: 55' from Paris down town, 1 hour 30 mn from Roissy Charles De Gaulle International airport, 2 hours 45 mn from Lille, 3 hours from Lyon, 5 hours from Marseille.

Acces Map

Back