This book provides a detailed account of the most recent developments, challenges and solutions to seamlessly advance and launch lyophilized biologics or vaccine products, based on diverse modalities, ranging from antibodies (e.g., monoclonal, fusion), complex biologics (e.g., antibody drug conjugates,  PEGylated proteins) and vaccines (e.g., recombinant protein based). The authors adeptly guide you through everything you need to know, from biophysical and chemical stability considerations of proteins, to critical assessment during process scale-up, technology transfer, packaging, alternate drying and device selection for a successful process validation, regulatory submission and launch of a stable, safe and effective product.

Preface.- Part I - Lyophilization History and Fundamentals.- History of Lyophilization.- Heterogeneity of protein environments in frozen solutions and in the dried state.- Advance understanding of buffer behavior during lyophilization.- Advances in Instrumental Analysis Applied to the Development of Lyophilization Cycles.- New Developments in Controlled Nucleation: Commercializing VERISEQ® Nucleation technology.- Part II - Lyophilized Biologics and Vaccines - Modality Considerations.- Lyophilized Biologics.- Lyophilization of Therapeutic Proteins in Vials - Process Scale-up and Advances in Quality by Design.- Advances in Process Analytical Technology in Freeze Drying.- Process Scale-up and Optimization of Lyophilized Vaccine Products.- Stabilization of Plasmid DNA and Lipid-based Therapeutics as Dehydrated Formulations.- Part III - Advances in Alternate Drying.- Alternatives to Vial Lyophilization.- Spray Drying of Biopharmaceuticals.- Current Trends and Advances in Bulk Crystallization and Freeze Drying of Biopharmaceuticals.- Case Studies and Examples of Biopharmaceutical Modalities.- Processed by Bulk Crystallization or Bulk Freeze Drying.- Part IV- Regulatory, Packaging and Technology Transfer Considerations.- Lyophilization of Biologics - An FDA Perspective.- Recent Trends in Lyophilized Delivery Devices and Packaging.- Lyophilization Technology Transfer towards Product Launch.