Functional collaborations required to successfully validate a Mab process at a C - Seguridad Mania.com - España y América Latina

Technology transfer leading to a successful validation of a Monoclonal Antibody process at a CMO site is a complex task that would need seamless interaction between various functions of the sending and receiving organizations. The success of the process is very much dependent on the technical depth, personal trust and the strength of the relationships established between the team members across the various functions in both organizations. The interactions begin with the due diligence process and builds through laboratory scale technology transfer leading to engineering/GMP campaigns and ends with a successful validation.  Depending on the stage in development of the molecule being technology transferred, the sending organizations could have personnel involved from both development and manufacturing making the process more complex. This write up will outline the role played by the various functions starting from Technical Services to Quality Assurance and will include functions like Shipping and Supply Chain.