This book provides a detailed account of the most recent
developments, challenges and solutions to seamlessly advance and
launch a lyophilized biologics or vaccine product, based on diverse
modalities, ranging from antibodies (e.g., monoclonal, fused),
complex biologics (e.g., antibody drug conjugate, PEGylated
proteins), and vaccines (e.g., recombinant-protein based). The
authors adeptly guide the reader through all crucial aspects, from
biophysical and chemical stability considerations of proteins,
analytical methods, advances in controlled ice nucleation and
quality-by-design approaches, alternate drying technology, to
latest regulatory, packaging and technology transfer considerations
to develop a stable, safe and effective therapeutic protein,
vaccine and biotechnology products. Lyophilized Biologics and
Vaccines: Modality-Based Approaches is composed of four sections
with a total of 17 chapters. It serves as a reference to all
critical assessments and steps from early pre-formulation stages to
product launch: Provides recent understanding of heterogeneity of
protein environment and selection of appropriate buffer for
stabilization of lyophilized formulations Details the latest
developments in instrumental analysis and controlled ice nucleation
technology Explains in-depth lyophilized (or dehydrated)
formulation strategies considering diverse modalities of biologics
and vaccines, including plasmid DNA and lipid-based therapeutics
Details an exhaustive update on quality-by-design and process
analytical technology approaches, illustrated superbly by case
studies and FDA perspective Provides the latest detailed account of
alternate drying technologies including spray drying, bulk
freeze-drying and crystallization, supported exceptionally by case
studies Provides a step-by-step guide through critical
considerations during process scale-up, technology transfer,
packaging and drug delivery device selection, for a successful
lyophilization process validation, regulatory submission and
product launch Chapters are written by one or more world-renowned
leading authorities from academia, industry or regulatory agencies,
whose expertise cover lyophilization of the diverse modalities of
biopharmaceuticals. Their contributions are based on the exhaustive
review of literature coupled with excellent hands-on experiences in
laboratory or GMP setup, making this an exceptional guide to all
stages of lyophilized or dehydrated product development.
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