By Dushyant Varshney, Manmohan Singh
This booklet offers an in depth account of the latest advancements, demanding situations and options to seamlessly improve and release a lyophilized biologics or vaccine product, in response to various modalities, starting from antibodies (e.g., monoclonal, fused), advanced 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 tools, advances in managed ice nucleation and quality-by-design ways, trade drying expertise, to most recent regulatory, packaging and know-how move issues to enhance a strong, secure and potent 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 serious checks and steps from early pre-formulation levels to product release:
- Provides contemporary figuring out of heterogeneity of protein surroundings and choice of acceptable buffer for stabilization of lyophilized formulations
- Details the most recent advancements in instrumental research and regulated ice nucleation know-how
- Explains in-depth lyophilized (or dehydrated) formula suggestions contemplating assorted modalities of biologics and vaccines, together with plasmid DNA and lipid-based therapeutics
- Details an exhaustive replace on quality-by-design and approach analytical expertise techniques, illustrated fantastically by way of case experiences and FDA perspective
- Provides the most recent targeted account of exchange drying applied sciences together with spray drying, bulk freeze-drying and crystallization, supported highly via case studies
- Provides a step by step advisor via serious issues in the course of method scale-up, expertise move, packaging and drug supply machine choice, for a profitable lyophilization strategy validation, regulatory submission and product launch
Chapters are written by means of a number of world-renowned prime experts from academia, or regulatory firms, whose services conceal lyophilization of the varied modalities of biopharmaceuticals. Their contributions are in line with the exhaustive evaluation of literature coupled with first-class hands-on studies in laboratory or GMP setup, making this a very good consultant to all levels of lyophilized or dehydrated product development.
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Extra info for Lyophilized Biologics and Vaccines: Modality-Based Approaches
Remmele R, Jr, Krishnan S, Callahan, W. Development of stable lyophilized protein drug products. Curr Pharm Biotech. 2012;13:471–96. Advance Understanding of Buffer Behavior during Lyophilization 41 40. Shalaev EY. The impact of buffer on processing and stability of freeze-dried dosage forms. Part. 1 Solution freezing behavior. Am Pharm Res. 2005;8:80–7. 41. Shalaev EY, Franks F. Solid-liquid state diagrams in pharmaceutical lyophilization: crystallization of solutes. In: Levine H, editor Progress in amorphous food and pharmaceutical systems.
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. Pharm Dev Technol. 2007;12:505–23.
The concept of ‘structure’ in amorphous solids from the perspective of the pharmaceutical sciences. Amorphous food and pharmaceutical systems. Cambridge: The Royal Society of Chemistry; 2002. 11–30. 23. Izutsu K, Kojima S. Freeze-concentration separates proteins and polymer excipients into different amorphous phases. Pharm Res. 2000;17(10):1316–22. 24. Padilla AM, Pikal MJ. Phase separation of freeze-dried amorphous solids: the Occurrence and detection of multiple amorphous phases in pharmaceutical systems.