by Atanas V. Koulov, Satish K Singh
Surfactants in Biopharmaceutical Development addresses
the progress, challenges, and opportunities in surfactant research in
the context of the development of biologic therapeutics. It has been
widely recognized that surfactants provide protection to therapeutic
proteins against interfacial stresses, which is the reason that nearly
all therapeutic proteins in development and on the market today contain
surfactants. Despite the fact that the very mechanism of protein
stabilization by surfactants has not been completely understood,
surfactants are universally regarded as critical functional excipients
for biopharmaceuticals by the industry and by regulators. This book
provides a broad range of important surfactant-related topics as they
relate directly to biopharmaceutical development. The initial chapters
of the book address fundamental topics, like synthesis of surfactants,
mechanisms of protein stabilization by surfactants, as well as practical
considerations for the use of surfactants in biomanufacturing. Later
chapters provide overview of the state-of-the-art analytical technology
and methods for quantification and characterization of surfactants, as
well as a deep-dive in one of the hottest topics in biopharmaceutical
development today – surfactant degradation and its impact to drug
product quality and stability. The book concludes with forward-looking
chapters on control strategies with a special focus on current
regulatory aspects of paramount importance for biopharmaceutical
companies and regulators.
- Describes
the current state of research on surfactants in the context of
biopharmaceutical development, drawing upon contributions from
international experts across industry, academia, and regulators
- Addresses the opportunities and challenges associated with surfactants in biologic drug development
- Provides
a defining resource for practitioners in the biopharmaceutical
industry, regulators and academics by summarizing the latest knowledge
of surfactants in biopharmaceutical development in one comprehensive
volume
