Technology transfer: The key to a successful product commercialization

Joint Event on 6^th International Conference and Exhibition on GMP, GCP & Quality Control & 7^th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR

September 25-26, 2017 Chicago, USA

Jose Zayas

Ionetix Corporation, USA

Posters & Accepted Abstracts: Pharm Regul Aff

Abstract :

The process of technology transfer is most often focused on the technical aspects of the processes being transferred. However, the actual process is one more closely related to knowledge transfer. The technical portions of the process are best captured by project management tools that sometimes underestimate the training and experience aspects of the process. Commercialization processes in startup operations can make or break a project, and sometimes the company. Careful considerations of all aspects of the product, from its development, all the way to the proposed commercial process have to be considered. The process or technology transfer is best defined by considering that it is a process of transfer of knowledge. It has to consider experiences, documentation, careful attention to detail, as well as, all variable related to scale, facilities, process flow, and personnel. Instrumentation and equipment are controlled variables. Others, such as environmental conditions and people become variables that are not often considered as a major hurdle. This presentation deals with a holistic approach to the technology transfer process, when does it start, and does it ever end.