By Dushyant Varshney, Manmohan Singh
This booklet offers a close account of the newest advancements, demanding situations and ideas to seamlessly boost and release a lyophilized biologics or vaccine product, according to assorted modalities, starting from antibodies (e.g., monoclonal, fused), complicated biologics (e.g., antibody drug conjugate, PEGylated proteins), and vaccines (e.g., recombinant-protein based). The authors adeptly consultant the reader via all an important facets, from biophysical and chemical balance concerns of proteins, analytical tools, advances in managed ice nucleation and quality-by-design methods, exchange drying expertise, to newest regulatory, packaging and know-how move concerns to increase a sturdy, secure and powerful healing protein, vaccine and biotechnology products.
Lyophilized Biologics and Vaccines: Modality-Based Approaches consists of 4 sections with a complete of 17 chapters. It serves as a connection with all severe exams and steps from early pre-formulation levels to product release:
- Provides fresh knowing of heterogeneity of protein surroundings and choice of applicable buffer for stabilization of lyophilized formulations
- Details the newest advancements in instrumental research and regulated ice nucleation know-how
- Explains in-depth lyophilized (or dehydrated) formula innovations contemplating different modalities of biologics and vaccines, together with plasmid DNA and lipid-based therapeutics
- Details an exhaustive replace on quality-by-design and technique analytical know-how ways, illustrated fantastically by way of case reports and FDA perspective
- Provides the most recent targeted account of exchange drying applied sciences together with spray drying, bulk freeze-drying and crystallization, supported quite by way of case studies
- Provides a step by step consultant via serious concerns in the course of technique scale-up, expertise move, packaging and drug supply gadget choice, for a winning lyophilization strategy validation, regulatory submission and product launch
Chapters are written via a number of world-renowned best specialists from academia, or regulatory enterprises, whose services disguise lyophilization of the varied modalities of biopharmaceuticals. Their contributions are in keeping with the exhaustive assessment of literature coupled with very good hands-on reports in laboratory or GMP setup, making this a superb consultant to all levels of lyophilized or dehydrated product development.
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Extra resources for Lyophilized Biologics and Vaccines: Modality-Based Approaches
Sample text
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