By Dushyant Varshney, Manmohan Singh
This ebook offers an in depth account of the latest advancements, demanding situations and suggestions to seamlessly increase and release a lyophilized biologics or vaccine product, in keeping with diversified 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 advisor the reader via all the most important features, from biophysical and chemical balance issues of proteins, analytical tools, advances in managed ice nucleation and quality-by-design ways, trade drying know-how, to most up-to-date regulatory, packaging and know-how move concerns to advance 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 tests and steps from early pre-formulation levels to product release:
- Provides fresh figuring out of heterogeneity of protein setting 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 various modalities of biologics and vaccines, together with plasmid DNA and lipid-based therapeutics
- Details an exhaustive replace on quality-by-design and procedure analytical expertise techniques, illustrated beautifully via case experiences and FDA perspective
- Provides the most recent specified account of trade drying applied sciences together with spray drying, bulk freeze-drying and crystallization, supported really by way of case studies
- Provides a step by step consultant via severe issues in the course of approach scale-up, know-how move, packaging and drug supply machine choice, for a winning lyophilization procedure validation, regulatory submission and product launch
Chapters are written by way of a number of world-renowned major professionals from academia, or regulatory organisations, whose services conceal lyophilization of the varied modalities of biopharmaceuticals. Their contributions are in keeping with the exhaustive evaluation of literature coupled with very good hands-on reviews in laboratory or GMP setup, making this a superb consultant to all levels of lyophilized or dehydrated product development.
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Extra info for Lyophilized Biologics and Vaccines: Modality-Based Approaches
The change in color from solution to lyophile reflects significant change in the extent of protonation of the indicator and therefore major shift in the apparent acidity during freeze-drying. 0) Phosphate Buffer Phosphate buffer is widely used and has been extensively studied in the pharmaceutical field. As early as the 1950s, Van den Berg conducted pioneering work to describe the effect of freezing on phosphate buffer system under equilibrium conditions . Van den Berg showed that the pH and composition of maximally freeze-concentrated solutions can be defined by the eutectic point and is independent of both the initial pH and buffer concentration for sodium phosphate buffer and potassium phosphate buffer.
Progress in amorphous food and pharmaceutical systems. Cambridge: The Royal Society of Chemistry; 2002. 200–15. 8. Scheiwe MW, Korber Ch, Wollhover K. Cryomicroscopical analysis of solute polarization during freezing. Cryobiology. 1982;19(6):652. 9. Scheiwe MW, Korber Ch, Wollhover K. Relevance of thermally defined cryomicroscopy and thermodynamic analysis for cryopreservation. Cryobiology. 1982;19(6):653. 10. Singh SK, Kolhe P, Wang W, Nema S. Large-scale freezing of biologics-a practitioner’s review part 1: fundamental aspects.
Cocks FH, Brower WE. Phase diagram relationships in cryobiology. Cryobiology. 1974;4:340– 258. 5. Shalaev E, Franks F. Changes in the physical state of model mixtures during freezing and drying: impact on product quality. Cryobiology. 1996;33:14–26. 6. Franks F, Auffret T. Freeze-drying of pharmaceuticals and biopharmaceuticals. Cambridge: RSC Publishing; 2007. 206. 7. Shalaev E, Franks F. Solid-liquid state diagrams in pharmaceutical lyophilisation: crystallisation of solutes. In: Levine H, editor.