As FDA gears up towards approving biosimilar drugs in the United States, it is unquestionable that the role of biologics has rapidly expanded in healthcare, raising questions and presenting crucial issues associated with their quality and efficacy. Unlike small-molecule medicines, which have more easily defined quality attributes and are relatively easy to characterize, biologics are large-molecule drugs, typically manufactured using living cells. Because biologic medicines range from simple structures like certain peptides to complex mixtures, such as vaccines, establishing meaningful quality attributes for each specific product can present challenges.
Besides serving a much reduced patient population because of their specific applications, biologics manufacturing requires living material and a much more complicated process than small-molecule synthesis, making a biologic drug naturally more costly.
USP standards for mAbs
Currently, licensed monoclonal antibody (mAb) therapeutics include those involved in the activation of effector cells, cell killing, cross-linked induced apoptosis, antagonism against several targets, and agonist antibodies. Because of structural similarities between antibodies of the same class, the United States Pharmacopeial Convention’s (USP) expert panel decided to focus its efforts in developing standards for mAbs on a class of molecules that would be more amenable to a “platform approach” both in terms of manufacturing and analytical development.
Via Dominique Blanchard