Novasep Process: Pharmaceutical Custom Purification

Purification Services from Lab to Industrial Scale

Novasep Process offers purification services for pharmaceuticals, fine chemicals, cosmetics and food ingredients including:

• Fine chemicals, synthetic intermediates and APIs
  - Chiral separations
  - Isolation of molecules from complex reaction mixtures
  - Purification of synthetic peptides
  - Highly potent compounds
• Purification of natural extracts
• Purification facilities
  - 4 cGMP, FDA-inspected sites equipped with our large-scale chromatography technologies, ultra-modern and fully automated facilities.
  - The capacity of Novasep Process chromatography systems ranges from grams to metric tons, offering an unparalleled chromatography purification capacity on a single production site.

Novasep custom purification services include purification of pre-clinical and phase I through III products, process validation and separation / purification of commercial intermediates and APIs.

Chromatography Equipment

	Column size	Production capacity
Preparative HPLC: Hipersep®, Cyclojet®	50, 80, 110, 150, 200, 300 and 450mm internal diameter	Grams to metric ton
Varicol® multicolumn Continuous chromatography	10, 25, 50, 200, 300 and 600mm internal diameter	Grams to 100 metric tons
Supercritical fluid chromatography (SFC): Supersep™	20, 30, 50mm internal diameter	Grams to kg's

This high performance chromatography equipment, designed by Novasep Process, integrates the latest technological developments, with more than 20 years of experience in the design and engineering of innovative chromatography processes.

Novasep Process answers your evolving needs, from early development to commercial stage, using batch processes (HPLC or SFC) to quickly produce early development compounds and reduce time to market and continuous processes (Varicol®) to optimize commercial production costs.

Mastery of the Complete Process

Clean rooms are used for solid handling. Each clean room is dedicated to a production line, to avoid cross-contamination.

Integrating automatic solvent recycling considerably minimizes VOC’s and operating costs (solvents, waste) for large scale purification campaigns. Falling film evaporators are coupled to the chromatography systems with a fully automated solvent recycling, including patented solvent composition adjustment.

Dryers and crystallizers are available to isolate purified molecules from concentrated purified fractions, mastering the process according to your specifications, based on our strong expertise in crystallization (polymorphism, particle size, etc.).

Global Purification Offering

• The Pompey site was FDA-inspected in 2005. No FDA 483 Form was issued.
• The Chasse-sur-Rhône and Mourenx sites are FDA inspected (last inspection in May 2007)
• The Le Mans site is equipped with large-scale HPLC and cytotoxic facilities. It is FDA inspected.
• Important resources are dedicated to Quality Control and Quality Assurance
• Regulatory support is provided by Novasep Process, including process validation and DMF drafting and filing.
• A large array of in-house analytical equipment is available: HPLC-MS, FTIR, NMR, GC, GC-MS, GC-Headspace, UV, Karl -Fisher, Dry residues analysis, DSC, heavy metals, residues on ignition, etc.

Benefits and Advantages

Novasep Contract Purification Solutions challenge Industry Standards

• Custom purifications according to customers’ processes can be scaled-up and achieved, typically to comply with regulatory constraints. However, with Novasep Process unique expertise in purification process development and optimisation, more efficient processes can often be implemented, with all product-specific IP belonging to the customer.
• Added value of Novasep Process’s strong IP position: VARICOL® and Cyclojet® processes are proprietary to Novasep Process. Therefore, generic products can be purified using innovative and non infringing processes.
• Project-based collaboration with Novasep Synthesis: global outsourcing solution for multi-step organic syntheses including separation step(s), racemization of non desired enantiomer for chiral syntheses, etc.
• Access to Novasep Synthesis’ HPAI (Highly Potent Active Ingredients) development and production capacities.
• Solution for in- and out-sourcing needs: unique ability to transfer a process based on Novasep Process technologies to our customers.