Novasep, a leading supplier of manufacturing solutions to the life science industries, and instrAction, a manufacturer of innovative chromatographic stationary phases for API purification processes, have entered into a strategic alliance. The alliance will offer customers in the pharmaceutical industry a unique combination of 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 and operate or supply optimized large scale chromatography processes for purifying synthetic and semi-synthetic compounds.
This combined approach will provide a purification process or service with guaranteed, optimized and cost-effective performance. It will enable pharmaceutical companies using Novasep’s and instrAction’s services to secure key process intellectual property for their valuable molecules including new molecular entities and generic active pharmaceutical ingredients (API).
For each customer molecule, at the customer’s option, instrAction will identify the API-selective stationary phase most appropriate to customer needs from its library of over 3,000 phases, constantly expanded by new prototypes, and perform process optimization services assisted by Novasep with the latter’s unique 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 crystallization, and even normal or reversed phase chromatography, are often too expensive, and, worse, ineffective,” says 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 are looking forward to expanding their use to provide our customers with a substantial benefit compared with traditional purification processes,” he added.
“We are delighted at our extended collaboration with Novasep, the undisputed leader of industrial chromatography in the pharmaceutical industry,” said Dr Thomas Schwarz, CEO of instrAction GmbH. “We believe that together, instrAction and Novasep will develop solutions that will provide great improvement in the purification of a number of pharmaceutical compounds. Moreover, we believe that our joint approach with a single point of contact and streamlined project management will help reduce process development timelines.”
Novasep develops, markets and operates innovative technologies providing life science industries with safe and cost-effective production of active molecules.
instrAction, founded in 1997 by Dr Klaus Gottschall and located at the BASF site in Ludwigshafen, develops and manufactures “Instruction Receptor Phases” as novel API-selective resins for chromatography.