Chromatography: Custom Purification

Novasep Process offers purification services under cGMP conditions for pharmaceuticals, fine chemicals, cosmetic 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

Capacity of Novasep chromatography systems ranges from grams to multi-metric tons, offering an unparalleled chromatography purification capacity on a single production site.

Four large scale purification lines are available, as well as multiple lab/kilo-lab purification equipment including:

• Hipersep® and Cyclojet systems with columns of up to 450mm i.d.
• Varicol® 8-50, 6-200, 6-300, with columns of up to 300mm i.d.
• Supersep™ 10, 50 (with CO2 recycling).
• Falling films evaporators: 4 units made of stainless steel and 1 unit made of Hastelloy C22
• Various rotary evaporators (with capacity up to 8 kg/hr water)
• Solvent recycling with automatic adjustment of composition
• Miscellaneous equipment: dryers (filter-dryer up to 40 kg and conical dryers up to 250 kg), grinder, etc.
• All systems feature full automation and total solvent recycling capabilities.

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

Novasep 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 processes and costs to produce late clinical and commercial products.

Mastery of the Complete Process

The organisation of the multi-purpose plant of Novasep SAS (Pompey site) is made in such a way that there is no possibility of cross-contamination between incoming and outgoing products and between different products that are purified at the same time.

• Clean rooms are present for solid handling. Each clean room is associated to a production line
• Integration of automatic solvent recycling considerably minimizes COV’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 automatic 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.).
  

Quality Assurance and Regulatory

• AFSSAPS (French regulatory body) inspection in 2005
• Important resources dedicated to Quality Control and Quality Assurance
• Regulatory support is provided by Novasep, including process validation and DMF drafting and filing.
• A large array of in-house analytical equipment: HPLC, GC, GC-Headspace, UV, Karl-Fisher, Dry residues analysis, DSC, heavy metals, residues on ignition, etc.

Added benefits

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