Our Technical Development Group understands the needs of large scale manufacturing. Our teams are committed to using integrated development approaches that comprise all stages of product development, from cloning to formulation, with the goal of combining innovation and process economics.
With its proprietary Npro Autoprotease Fusion Technology (NAFT), Sandoz developed a tool for the improved expression and isolation of fusion proteins. This system leads to controllable, quantitative and autoproteolytic cleavage resulting in an authentic N-terminus. This effective and high yielding expression technology complements our production technology, offering a highly cost competitive option for the manufacture of peptides and proteins.
Our broad range of specialized facilities provides greater flexibility in the development and production of recombinant microbial products. We are able to develop and scale up processes, manufacturing the quantity levels required throughout the various stages of the development process – ranging from pre-clinical use through all clinical stages and commercial supply. This includes services for development and production of the active substance and finished product including quality, analytical and regulatory support. In addition, our cell culture facilities are capable of generating quantities of product that serve all stages of clinical development as well as supply commercial operations.
Sandoz offers state-of-the-art analytical services to accompany all stages of process development and commercial scale manufacturing: our experts provide the technical expertise and know-how when it comes to the testing and characterization of recombinant proteins.
Sandoz is the pioneer and undisputed global leader in the rapidly emerging market for biosimilars.