Book description
This book describes how to address the analysis of aggregates and
particles in protein pharmaceuticals, provides a comprehensive overview
of current methods and integrated approaches used to quantify and
characterize aggregates and particles, and discusses regulatory
requirements. Analytical methods covered in the book include separation,
light scattering, microscopy, and spectroscopy.
HANNS-CHRISTIAN MAHLER
is Head of Pharmaceutical and Device Development, Pharma Technical
Development Biologics Europe at F. Hoffmann-La Roche Ltd. He is also
Lecturer at the Institute for Pharmaceutical Technology at the
University of Frankfurt/Main, Germany.
WIM JISKOOT is Professor and Head of the Biologics Formulation
Group in the Leiden/Amsterdam Center for Drug Research (LACDR) at
Leiden University.
