Solvias AG wins European Outsourcing Award 2009
The task for Solvias was to develop, validate and perform tests for batch release including comparability and stability studies. The analysis of Mifamurtide was not only challenging due to the physical and chemical properties of the molecular entities themselves but these challenges were compounded by the need for a transition from older methods to ones that meet current standards within a tight timescale. The project’s success was also due to teamwork, as close collaboration between the three key contract manufacturers - based in Switzerland (drug substance), Japan (lipids) and the US (drug product) – was necessary. The strategy of separating analysis from manufacturing requires strong project management but has proven to be a cost effective model that has met all the sponsor’s demands. IDM Pharma’s MEPACT ® (Mifamurtide, L-MTP-PE) received approval in Europe in March 2009 for treatment of patients with high-grade resectable non-metastatic osteosarcoma.
“We are very proud to have contributed to the success of our customer and to this project, which provided us with the opportunity to win the European Outsourcing award. The award is a great honour for Solvias and a testimonial to our competence in handling complex, analytical tasks within strict deadlines to support our customers in a cost effective way”, stated Dr. Hansjörg Walther, CEO of Solvias AG.
This was not the first Outsourcing Award for Solvias. The company also received an Award in 2005 together with Novasep in the “Outstanding Application” category showing the technological maturity of transition-metal-catalyzed reactions on a production scale. In 2007 the award was again won, this time for a integrated chemical and analytical development project in the “Most Effective Scale-Up /Tech Transfer” category for a complex API intended for use in toxicology studies.
The most recent award was conferred during CPhI 2009 Madrid in October and rewarded an analytical contract project, which provided a fully integrated approach to pharmaceutical product development. The judges looked for evidence of a partnership that found the most rapid and cost-effective route to move a drug candidate from development to commercialization. Judging criteria included: Quality of material put place, timeframe, documentation quality, global QA system level, availability and flexibility, qualification and validation level of facilities, apparatus and process.
About the European Outsourcing Award
Launched in 2005, the European Outsourcing Awards recognizes significant developments in contract services and rewards successful companies for their outstanding contributions and achievements throughout the year. The awards were created to celebrate and recognize excellence in R&D, marketing, business and technology across the pharmaceutical industry. More: www.europeanoutsourcingawards.com
