Sets new standard for small molecule purification processes
Novasep, a French supplier of manufacturing solutions to the life science industries, and instrAction, a German producer of chromatographic stationary phases for API purification processes, have agreed to combine instrAction’s proprietary API-selective stationary phases (Instruction Receptor Phase) and Novasep purification capabilities and high performance chromatography technologies. These will be used to develop optimised large-scale chromatography processes for purifying synthetic and semi-synthetic compounds.
The firms say this combined approach will provide a purification process with guaranteed, cost-effective performance. It will enable pharmaceutical companies using Novasep’s and instrAction’s services to secure key process intellectual property for their new molecular entities and generic APIs.
For each customer molecule instrAction will identify the most appropriate API-selective stationary phase from its library of more than 3,000 phases and perform process optimisation services assisted by Novasep’s computer simulation software. Depending on individual customer requirements, there will be two options after development: either purification and if required synthesis by Novasep, or transfer of the process to the customer including the supply of a turnkey chromatography process system with guaranteed performance by Novasep and the supply of the API-selective stationary phase by instrAction.
‘With the ever-increasing complexity of pharmaceutical compounds, traditional purification processes including crystallisation, and even normal or reversed phase chromatography, are often too expensive, and, worse, ineffective,’ said René De Vaumas, executive vice president in charge of Novasep Synthesis’ business development.
‘InstrAction’s API-selective stationary phases have already demonstrated dramatically improved purification costs for several difficult-to-purify compounds at medium to large scale.’
‘We believe that, together, instrAction and Novasep will develop solutions that will provide great improvement in the purification of a number of pharmaceutical compounds,’ added Thomas Schwarz, ceo of instrAction.
‘Moreover, we believe that our joint approach with a single point of contact and streamlined project management will help reduce process development timelines.’