platform technology
(1) The term “platform technology” means a well-understood and reproducible technology, which may include a nucleic acid sequence, molecular structure, mechanism of action, delivery method, vector, or a combination of any such technologies that the Secretary determines to be appropriate, that the sponsor demonstrates— (A) is incorporated in or utilized by a drug or biological product and is essential to the structure or function of such drug or biological product; (B) can be adapted for, incorporated into, or utilized by, more than one drug or biological product sharing common structural elements; and (C) facilitates the manufacture or development of more than one drug or biological product through a standardized production or manufacturing process or processes.