A growing number of APIs, imaging agents, cosmetics, functional ingredients and other fine chemicals are based on:
Such types of molecules cannot be prepared using classic means and often require special chemistry combined with advanced downstream processing.
Indeed, because of their charge or polarity, these molecules tend to be water soluble and can exist as salts. Their purification from complex mixtures often requires a combination of technologies which may include adsorption, ion exchange, reversed phase, size exclusion or other types of chromatography. Moreover, such kinds of compounds are often thermally labile and, thus, require the use of membrane filtration such as ultrafiltration, nanofiltration or reverse osmosis for the concentration of the purified product under mild conditions. The final drying may require crystallization or spray drying.
As part of our purification process development services, we can investigate multiple alternatives and choose the most appropriate technology or combination of techniques for the purification of your molecule.
Novasep has unique expertise and capabilities in combining chemistry with advanced purification steps. Our chemists can scale up syntheses that include hazardous chemistry, chiral chemistry, highly potent API handling and other advanced organic reactions such as biocatalysis; while our purification specialists are able to fully develop challenging purification processes from A to Z.
Our in-depth know-how in coupling special chemistry with extensive downstream processing is completed by dedicated cGMP and FDA inspected capabilities, including a large number of kilo-lab, pilot and industrial scale batch chromatography and SMB plants, from low to high pressure, and several ion exchange, adsorption and membrane filtration units.
This combination of chemistry and purification is fully integrated in our offering for the large-scale manufacture of APIs and fine chemicals. We are always ready to discuss the scale-up of our customers’ projects to large commercial scale and the investment in purpose-designed facilities, in order to develop optimized processes and manufacturing plants.
Our expertise in preparative chromatography for synthetic molecules includes normal and reversed-phase adsorption chromatography as well as chiral chromatography using:
In addition, thanks to our know-how in chromatography for applications such as biopharmaceuticals, food ingredients, functional ingredients and bio-industries, we can design and operate other chromatographic modes such as affinity, size exclusion and ion-exchange chromatography using:
Our expertise in Tangential Flow Filtration (TFF), using Novasep proprietary ceramic or polymeric membranes or membranes from another supplier, enables us to quickly develop micro-, ultra-, nano-, dia-filtration and reverse osmosis processes.
Principles of Tangential Flow Filtration (click here to see the animation)
We routinely develop crystallization processes to improve the purity of APIs or intermediates or to improve particle size distribution and shape. This helps to speed up filtration steps or to obtain and control the polymorphism of APIs.
We also have pilot-scale spray drying capabilities (and many other drying capabilities at any scale).
Discover our unique palette of technologies for synthetic molecules:
Download our brochures for synthetic molecule manufacturing.
Contact us for any synthetic molecule manufacturing request.