Table 14.2.

Differences between pharmaceuticals and biopharmaceuticals

Characteristic	Pharmaceuticals	Biopharmaceuticals
Active ingredient	Simple molecule, any chemical compound	Large and complex molecule, protein
Sources	Chemicals	Living organism, plants, animals
Structure and characterization	Well defined chemical structure and finished products can be analyzed	Not well defined structure and very difficult to characterize
Compound’s integrity	Chemically synthesized, always the same compound, and can be identified analytically	Activity affected by the production cell system, fermentation media, and operating conditions
Impurity	Predictable impurity	Unpredictable and difficult to identify
Production process	Simple, well defined synthetic routes; can be produced in large quantities	Complex production routes; produced in small quantities
Dosage forms	Variable	Usually injectable
Variations among manufacturers	No variation among different manufacturers	Manufacturer to manufacturer variation is possible
Bioequivalence	Criteria defined	Unknown, hard to define