Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars.
Summary of "Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars."
Biologics such as monoclonal antibodies are much more complex than small-molecule drugs, which raises challenging questions for the development and regulatory evaluation of follow-on versions of such biopharmaceutical products (also known as biosimilars) and their clinical use once patent protection for the pioneering biologic has expired. With the recent introduction of regulatory pathways for follow-on versions of complex biologics, the role of analytical technologies in comparing biosimilars with the corresponding reference product is attracting substantial interest in establishing the development requirements for biosimilars. Here, we discuss the current state of the art in analytical technologies to assess three characteristics of protein biopharmaceuticals that regulatory authorities have identified as being important in development strategies for biosimilars: post-translational modifications, three-dimensional structures and protein aggregation.
Analytical Development, Biogen Idec, 14 Cambridge Center, Cambridge, Massachusetts 02142, USA.
This article was published in the following journal.
Name: Nature reviews. Drug discovery
Medical and Biotech [MESH] Definitions
A branch of applied ethics that studies the value implications of practices and developments in life sciences, medicine, and health care.
Centers for acquiring, characterizing, and storing organs or tissue for future use.
Centers for collecting, characterizing and storing human blood.
GENETIC PHENOMENA characterizing IMMUNITY and the immune response.
The study of chance processes or the relative frequency characterizing a chance process.
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