Chromatography: Process development

Many projects at Groupe Novasep start with development. This includes many steps, from the development and optimisation of purification and/or synthesis processes, to the purification and/or production of highly pure compounds for clinical Phases I, II and III.   For the development of a process aimed at obtaining a given molecule, Novasep Process provides expertise and services in the following situations:

• For products entering Preclinical or Phase I clinical trials, our work is to find solutions as quickly as possible. Speed is the keyword.
• For products in late clinical phases or already on the market (including generics), we can design new processes or improve existing ones, in order to get better purity, yield and/or reduce manufacturing costs.

Our services range from rapid screening studies to complete process optimisations; and from the isolation of a few grams of products to the custom purification of tons of intermediates and APIs, for clinical Phases I, II and III.

The range of services of Novasep Process include the following activities:

• process development;
• scale-up;
• custom purification under cGMP;regulatory support, including process validation, DMF drafting and filing;
• process transfer at our customers’ sites;
• process performance guarantees.
  

Process Development and scale-up
 
Novasep Process has developed a unique expertise in separation process development, involving a unique pool of competencies in purification (Chromatography, Membranes, Crystallization, Extraction, Adsorption, Ion exchange).

All aspects of a purification process are taken into account. Through extensive use of its proprietary computer modeling software, feasibility of a large-scale purification process is determined, and purification price is estimated very early, whatever the scale. Pilot scale systems are operated for proof of concept runs, and then full development studies can be performed, including worst case scenarios. Using Novasep technologies, scale up is straightforward, prices and performances are guaranteed for large scale custom purification, and systems supplied to our customers.