Novasep Synthesis in Le Mans, France

HPAPIs Synthesis and Purification

Expertise & Activities

Novasep in Le Mans, France has a twenty year track record of success in highly potent API 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 HPAPIs, such as cytotoxics (Paclitaxel).

More recently, the Le Mans site has gained significant experience in the manufacture of antibody-drug conjugates (ADCs).

Novasep in 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

Overview

The Novasep site in Le Mans is located near the Le Mans University on a 20,000 m² site and includes:

• 3,000 m² in production space
• 1,000 m² in laboratories (including process and product development, quality control and labs)

Equipment & Capabilities

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.

Quality

This site is FDA inspected and SafeBridge® certified.

Click here to go the Novasep Le Mans Quality page.

Contact us

Novasep Le Mans site Rue Démocrite 72000 Le Mans FRANCE

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 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.

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