Download e-book for iPad: Lyophilized Biologics and Vaccines: Modality-Based by Dushyant Varshney, Manmohan Singh


By Dushyant Varshney, Manmohan Singh

ISBN-10: 149392382X

ISBN-13: 9781493923823

ISBN-10: 1493923838

ISBN-13: 9781493923830

ISBN-10: 1571792112

ISBN-13: 9781571792112

This publication offers a close account of the latest advancements, demanding situations and ideas to seamlessly develop and release a lyophilized biologics or vaccine product, in response to different 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 points, from biophysical and chemical balance concerns of proteins, analytical equipment, advances in managed ice nucleation and quality-by-design ways, trade drying know-how, to most modern regulatory, packaging and know-how move concerns to advance a reliable, 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 phases to product release:

  • Provides fresh realizing 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 expertise
  • Explains in-depth lyophilized (or dehydrated) formula concepts contemplating different modalities of biologics and vaccines, together with plasmid DNA and lipid-based therapeutics
  • Details an exhaustive replace on quality-by-design and procedure analytical know-how methods, illustrated fantastically by way of case reviews and FDA perspective
  • Provides the most recent specified account of exchange drying applied sciences together with spray drying, bulk freeze-drying and crystallization, supported exceedingly via case studies
  • Provides a step by step advisor via severe issues in the course of approach scale-up, know-how move, packaging and drug supply equipment choice, for a winning lyophilization procedure validation, regulatory submission and product launch

Chapters are written through a number of world-renowned major experts from academia, or regulatory businesses, whose services hide lyophilization of the various modalities of biopharmaceuticals. Their contributions are according to the exhaustive overview of literature coupled with very good hands-on reviews in laboratory or GMP setup, making this a superb advisor to all levels of lyophilized or dehydrated product development.

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Extra info for Lyophilized Biologics and Vaccines: Modality-Based Approaches

Sample text

Pharm Res. 1995;12:1457–61. 2. Alkhamis KA. Influence of solid-state acidity on the decomposition of sucrose in amorphous systems. Int J Pharm. 2008;362(1–2):74–80. 3. Bates RJ. Revised standard values for pH measurements from 0 to 95 C. J Res Natl Bureau Stand-A. Phys Chem. 1962;66 A. 4. Bates RG. Determination of pH: theory and practice. New York: Wiley; 1973.  222. 5. Bell LN, Labuza TP. Compositional influence on the pH of reduced-moisture solutions. J Food Sci. 1992;57:732–4. 6. Bottari E, Festa MR.

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. Bioprocess Int. 2009;7(10):32–44. 11. Singh SK, Kolhe P, Wang W, Nema S. Large-scale freezing of biologics: understanding protein and solute concentration changes in a cryovessel-Part 2. BioPharm Int. 2010;23(7). 12. Bhatnagar BS, Bogner RH, Pikal MJ. Protein stability during freezing: separation of stresses and mechanisms of protein stabilization.

Application of calorimetry, sub-ambient atomic force microscopy and dynamic mechanical analysis to the study of frozen aqueous trehalose solutions. Pharm Res. 2008;25:1396–404. 52. Varshney DB, Elliott JA, Gatlin LA, Kumar S, Suryanarayanan R, Shalaev EY. Synchrotron X-ray diffraction investigation of the anomalous behavior of ice during freezing of aqueous systems. J Phys Chem B. 2009;113:6177–82. 53. Franks HS, Wen WY. Ion-solvent interactions. Structural aspects of ion-slovent interactions: a suggested picture of water structure.

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Lyophilized Biologics and Vaccines: Modality-Based Approaches by Dushyant Varshney, Manmohan Singh

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