Challenges in achieving comparability, reproducibility and accuracy in biological assays has driven a demand for improved confidence in measurements that support development of regenerative medicine therapies.  There have been extensive discussions about the inability to reproduce biological research findings and two surveys of industry stakeholders have found that product consistency and lack of standards may be the single greatest challenge facing the field of regenerative medicine [1,2].  There are many strategies for achieving measurement assurance, such as reference materials, inter-laboratory testing and standard test methods.  However, there are challenges in applying these strategies to complex biological measurements which will require critical thinking to unravel.  

Learning Objective 1: Understand the concept of measurement assurance.

Learning Objective 2: Learn key measurement definitions: measurand, uncertainty, reference material, inter-laboratory comparability study.

Learning Objective 3: Learn strategies to achieve measurement assurance.