Recipharm has made a strategic investment to expand capacity for analytical services and stability studies at its facility in Solna, Sweden. The facility, which is equipped with advanced labs for pharmaceutical formulation and a GMP suite for development and manufacture of sterile and non-sterile clinical trial materials, will be reconstructed to facilitate the expansion of analytical development.
Analytical services will include: development and validation of stability indicating analytical methods, supply and execution of method transfer protocols, establishment of new product assay and degradation methods, graduated validation plans, cleaning validation, report writing and stability studies according to ICH. The company anticipates that the analytical lab in Solna will be ready and compliant with ICH, EU and FDA GMP in May 2013.
“This is a very important step for us as increasing this capacity will enable the company to enhance the high quality services to our customers,” said Maria Lundberg, general manager at Recipharm Pharmaceutical Development. “Our analytical development service is already an integrated and vital part of the pharmaceutical development work, and this investment will enable our business to continue to grow, creating more flexibility and a better service offering. We are convinced that it is vital to small and large pharma companies that competent service partners can supply high quality pharmaceutical development services including high quality analytical development.”