ABSTRACT
Biologic drugs are forming a larger and expanded part of the therapeutic drug market. The top ten best-selling drugs are currently a mix of small and large molecules, but it is expected that biologics will soon represent a large majority of the top-selling drugs. These drugs have a high degree of complexity and must be analyzed using information-rich analytical techniques to fully characterize the drug. Thus, biosimilar copies of these innovator drugs must also be intensively analyzed to ensure they have comparable analytical profiles. In this article we discuss the regulatory requirements for introducing a follow-on biologic, or biosimilar, drug on the market, how analytics in general can be used to reduce the need for comprehensive clinical trials, and how MS in particular is becoming increasingly valuable in these analyses.
Subject(s)
Biosimilar Pharmaceuticals/chemistry , Mass Spectrometry/methods , Amino Acid Sequence , Antibodies, Monoclonal, Humanized/chemistry , Antibodies, Monoclonal, Humanized/metabolism , Molecular Sequence Data , Proteolysis , Social Control, Formal , Trastuzumab , Trypsin/metabolismABSTRACT
Multidimensional reaction screening of ortho-alkynyl benzaldehydes with a variety of catalysts and reaction partners was conducted in an effort to identify new chemical reactions. Reactions affording unique products were selected for investigation of preliminary scope and limitations.
