Methodology for process characterisation in R&D to facilitate technology transfer in bio pharmaceuticals

Process characterisation is an important aspect of any validation program. This article presents arguments on how process characterisation should be integrated to the process of Research & Development (R&D) itself of a biopharmaceutical product. This makes the work of technical transference and validation easier in the last stages. Although the application of this methodology is time consuming for qualified personnel, its results are translated into greater efficiency of R&D as well as for the transfer of the technological package.

Keywords: R&, D, technology transfer, biopharmaceuticals