A Need for Enabling Technologies Facilitating these standards
will require the design and engineering of robust enabling
technologies to address development and manufacturing
challenges, and demonstrate product safety and/or efficacy.
These should be easy to use and provide reproducible results
across multiple locations and usage environments, despite
variation in user input. This approach also envisages the
repositioning of existing platform technologies that are
currently utilized outside the regenerative medicine field. Take
a specific example: the EC published Directive 2004/23/EC
concerning standards of quality and safety for the donation,
procurement, testing, processing, preservation, storage, and
distribution of human tissues and cells. Article 23 of this
directive requires establishments involved in distribution to
comply with specific requirements to ensure the quality of
tissues and cells during transit. Here is an opportunity to
develop enabling technologies that ensure that the environmental
cond