Quality control laboratories services

BSP Pharmaceuticals S.p.A. offers a wide range of services which includes quality control laboratories services. The facility houses chemical, biochemical and microbiological laboratories for the following typologies of analyses: analytical methods transfer/validation; product release testing and stability; cleaning controls; environmental monitoring; raw materials testing in compliance with cgmp. It includes. Our chemical laboratories quality control services includes: analytical methods transfer, ich compliant method validation, in process, product release and stability testing, cleaning methods development and validation, raw materials testing. Our microbiological laboratories provides assays suitable for regulatory submission aligned with several regulatory agency requirements and equipped to carry out tests, such as: analytical methods validation, product release testing and stability, environmental monitoring, cleaning controls, cleaning methods development and validation, raw materials testing in compliance with cgmp. Our biochemical laboratories has experience in establishing, validating and conducting routine bioassays according to cgmp standards. Fully validated assays suitable for regulatory submission are provided. Characterization work includes the determination of physicochemical and structural properties, purity, impurities and quantity of the monoclonal antibody, in line with ich q6b. The main services offer comprises: method transfer, ich compliant method validation, biopharmaceuticals product release testing, end-point binding measurements, in vivo bio-assay. Contact us for more information.