After the relocation and remodeling early 2013, the new laboratories of instrAction in the High Tech Park in Mannheim Janderstrasse 3 were officially opened. Now more than 500 m2 air-conditioned and ventilated with filtered air laboratory and pilot plant facilities are available for the development and production of instrAction® stationary phases. All rooms are connected to the central media supply with demineralized water and nitrogen. The bioseparation group gets two more "Äkta"-systems from GE Healthcare Life Sciences for process development of proteins in operation. Preparative HPLC chromatography, e.g. with our Novasep LC 50 column, can be done in a special fume hood in a new laboratory the process development group.
The increased work surface makes it possible to install fixed working stations for parallel synthesis of the stationary phases. This raises the productivity in the development of new stationary phases clearly.
The established quality management system of instrAction was fully transferred to the new site and the success has been certified by an external audit from the DEKRA.
In the last two years, the protection rights portfolio of instrAction GmbH was subject to a systematic revision. The foundation stone was laid for 7 new patent families (First application in Germany respective as a European patent application, entry into the international phase under PCT applications). This substance protection is strengthened to the year 2031. Other new applications are in preparation. The extensive prior patent portfolio has undergone a strategic streamlining with respect to the two view-points: useage or usability and cost. With both measures the goal of a strategic efficient property rights landscape in instrAction will be pursued. Apart from protecting the instrAction technology by own strategically aligned patent rights special attention is paid to freedom of operation. FTO analysis and monitoring of competitors have a high priority and will be extended. By entering into a cross-licensing agreement in the U.S. we have succeeded to attain freedom of operation for the instrAction technology in the U.S. market in an effective way. Thus, we successfully avoided a complicated and long lasting nullity process.
To accomplish the work on strategically oriented protection rights and on contracting the board has been actively and successfully supported by Werner Schwarz. As a physicist and after a long time of working as a scientist and developer in R&D he looks back on more than 15 years of full-time activity in the field of patent rights. During this time, Mr. Schwarz has setup, modernized and headed several industrial patent departments, in both as an employee and as a freelancer. Mr. Schwarz is both a member of VPP and of the Patent Legal Research Group of Prof. Bartenbach. He is also active as a speaker at seminars on patent system and is a lecturer at the Cooperative State University Baden-Württemberg in Karlsruhe.
Mr. Schwarz has been supporting instrAction as external consultant and will further assist the Board as of October as head of Patents and Contracting.
Mannheim - instrAction GmbH, as member CI3cluster of immunotherapy (Cluster for Individualized Immune Intervention), was awarded by the German Federal Ministry of Education and Research (BMBF), for the project "Design and scale-up of an innovative purification process for monoclonal antibodies", with a grant of € 290,000. instrAction´s expenditures for the projekt sum up to t a total of € 580,000. The project is implemented in collaboration with a renowned pharmaceutical company Latest results will be presented at the CI3 cluster conference on 17 September 2013 in Wiesbaden.
Further information on CI3 cluster of immunotherapy in the “Spitzencluster”-competition can be found under
netChrom®MLK: instrAction offers newly developed chromatographic material for the selective purification of Montelukast
Beginning of 2013 instrAction has successfully finalized some of their product developments. Based on the technology platform instrAction developed a molecule-specific phase (netChrom®MLK), for chromatographic purification of Montelukast which allows a significant more efficient and economical purification compared to the multi-stage crystallization process usually established in the downstream-processing sequence for the ingredient. Montelukast (trade name Singulair®) is an orally dosed drug for the treatment of mild to moderate asthma and allergic rhinitis. instrAction currently starts first negotiations for the out licensing of the technology to pharmaceutical drug manufacturers.
instrAction finalised a further study for development of innovative chromatography resins for endotoxin removal. The new chromatography phases base on the multi-modal instrAction technology and represent prototypes of new rugged resins with extraordinary clearance capacity for endotoxin. The resins provide new ways for endotoxin removal for proteins, API or other substances which would normally bind to anion exchange based endotoxin removal matrices. Further information is available on request.
The company's quality management system was certified in November 2012 according to the standard
DIN ISO 9001:2008