Contract Manufacturing, Finished Drug Product

A tremendous amount of analytical testing is required to support a biopharmaceutical product from discovery, development, and clinical trials, through manufacturing and marketing. Numerous methods are used to fully characterize large molecules because of their complexity-characterizing them is significantly more difficult than it is for small molecules. Biopharmaceuticals are produced via living systems, i.e., E. coli, yeast, or mammalian cells, which require additional testing matrices.

Disposables require less space than conventional equipment, and they can be assembled offsite into complete process trains.

Before designing cleaning procedures, it's vital to know all physical and chemical characteristics of the product ingredients.