Approved biological products composition

Table 3 Composition of Approved Biological Products (Continued)... 

There is so much concern about this issue that in some instances in the past, it has been considered preferable to increase the number of units instead of the scale of each unit of production to avoid potential differences in product quality. In some other instances, an approved biologic, even thought manufactured using less than ideal methods, may not be deemed to be replaced by a more advanced manufacturing method due to differences in the protein structure or composition. The market value of biologies and their complexity justifies this ultra conservative approach. 

The biological drug is not likely to be stable without the addition of additives like buffers, albumin, or surfactants if kept in a liquid form otherwise, an early conversion of the drug to a lyophilized form is completed. Most formulations would not include any preservative. Table 3 lists the recombinant products approved by the U.S. FDA and their composition. This table should serve as a good source to scout the most common additives found in these formulations. 

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