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Home / Products & Services / Pharmaceuticals / Chromatography equipement / Developing and optimizing your purification process
Developing and optimizing your purification process
Pharmaceuticals

Developing and optimizing your purification process

Bandeau13

With more than 40 successful purification process development projects every year, the development and optimization of chromatography processes is one our core areas of expertise.

We design, develop and optimize all kinds of chromatography steps from feasibility studies to process validation and qualification:

  • Batch or continuous operations
  • Supercritical fluid, high performance and low pressure chromatography
  • Reverse phase, ion exchange, adsorption, affinity, etc.
  • For large biomolecules, and small, natural or synthetic molecules

Our process development services include:

Screening and feasibility 
studies

Screening of media (resin, membranes, etc.), buffers, solvents…

Stability information, solubility studies, toxicological…

Process parameters screening

Process 
development

Simulation and modeling of the chromatography step


Model versus experiment


Optimization of selected conditions (flow rates, cycle times…)


Maximum capacities and limits determination

Industrialization and contract manufacturing

Scale-up


Robustness study


Fine tuning of small-scale parameters at large-scale


Production of the first grams or kilos at our premises

Production of demo/tox and pilot batches

Validation

Critical parameters determination


Proven Acceptable Range (P.A.R.) studies

Analytical method validation

Process validation before commercial phase    

 

Our process development teams are available worldwide (Europe, USA and China) to serve you better.
Going further, we can adapt to your manufacturing strategy and provide unique additional services:

  • Providing the adequate equipment and process with performance guarantees
  • Contract manufacturing services for early phases or before you get your own facilities
  • Facility set-up at Novasep dedicated to your product at late and commercial phases

A SOLID TRACK RECORD

Our track record includes processes for the purification of:

  • Recombinant molecules: insulin, factor VIII, factor IX, IFN-alpha, -beta, -gamma, IL-2, IL-11, Erythropoietin (EPO), DNA, RNA…
  • Small molecules (natural or synthetic) including multiple chiral APIs, statins, glycosides, alcaloids, antibiotics (cephalosporin, doxorubicin…), vitamin derivatives, omega-3s, lactoferrin, beta-lactoglobuline…
Downloads
  • ADC Brochure
    ADC Brochure
    size: 672.1K
    date: 07/09/2016
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