Guideline on the quality aspects of mRNA vaccines

其中制剂放行检测中要求检测Potency和Functionality

Potency：Potency of the finished product is determined by a combination of tests including evaluation of RNA content, mRNA integrity and efficiency of mRNA encapsulation.

Functionality：An antigen-specific cell-based functionality assay should be developed to confirm the LNP uptake, mRNA escape from the endosome and translation of the mRNA into encoded protein/antigen. Due to the limitations of such methods, this assay can be semiquantitative.

之前没有见过这种表述，想问问大家有什么区别？Functionality=Biological Activity？？

Functionality有没有明确的法规定义呢？