Recipharm, a contract development and manufacturing organization based in Sweden, has invested in expanding its capacity in analytical services and stability studies at its facility in Solna, Sweden.
The facility is equipped with advanced laboratories and technology for pharmaceutical formulation as well as a GMP suite for development and manufacturing of sterile and non-sterile clinical trial materials. It will now be reconstructed to facilitate expansion of analytical development within the Recipharm group.
"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.”
Analytical services normally included in the pharmaceutical offering comprise: 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 to suit the phase of drug development, cleaning validation, report writing and stability studies according to ICH. This expansion will mean that Recipharm will have the capability to support more projects in parallel with these services.
The analytical lab in Solna will be ready and fully compliant with ICH, EU and FDA GMP in May 2013.