ABSTRACT
Biological drugs, such as protein, are large molecule products that are gen-
erally produced using a living system or organism and may be manufac-
tured through biotechnology, derived from natural sources, or produced
synthetically. The expanded scope of a biological product includes any al-
pha amino polymer with a specific defined sequence that is greater than
40 amino acids in size and any alpha amino acid polymer that (1) is made
entirely by chemical synthesis and (2) is less than 100 amino acids in size.
