Combination of instrAction and Novasep know-how sets a new standard for small molecule purification processes for the life science industries.
Pompey, France and Ludwigshafen, Germany, 19th July 2010 -- 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, today announced that they 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. The global manufacturing solutions offered by Novasep include process development services; purification equipment and systems; contract manufacturing services; and complex active molecules. The applications of Novasep's offering cover the pharmaceutical, biopharmaceutical, food, functional ingredients and bio-industries markets.
The company has six FDA inspected manufacturing plants in France, Germany and the Bahamas, two biopharmaceutical production sites in Belgium, R&D and equipment manufacturing facilities in the USA, China and France, and an office in Japan. It employs approximately 1,300 people and had annual revenues of EUR 300 million in 2009. More than 2,000 systems designed and produced by Novasep are currently purifying active molecules throughout the world. The company holds more than 200 different patents covering its technologies and processes.
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. The Instruction® technology enables the immobilization of a wide variety of functional ligands on a polymer network, coated on very different porous backbone materials. Small molecules as well as substances with high molecular weight are separated by highly selective reversible interactions. The high selectivity of an instrAction stationary phase is thereby reached by multivalent-multimodal interactions between target molecule and the functional ligands of the phase, similar to the lock-and-key principle.