Lyophilized Biologics and Vaccines

This guide explores the complexities of developing lyophilized biologics and vaccines, offering insights into formulation, stability, and regulatory considerations throughout the product lifecycle.

This book provides a comprehensive overview of the latest advancements, challenges, and solutions in the development and launch of lyophilized biologics or vaccine products. Covering a range of modalities, including antibodies such as monoclonal and fused types, complex biologics like antibody-drug conjugates and PEGylated proteins, as well as various vaccine approaches, it serves as a vital resource for professionals in the field. The authors expertly navigate through essential topics, addressing biophysical and chemical stability considerations, analytical methods, controlled ice nucleation advancements, and quality-by-design strategies to ensure the creation of stable and effective therapeutic products.

Lyophilized Biologics and Vaccines is structured into four sections comprising 17 chapters, each designed to guide readers through critical assessments and steps from the initial pre-formulation stage to product launch. The book discusses the latest insights into the protein environment's heterogeneity and the selection of suitable buffers for stabilizing lyophilized formulations. Additionally, it highlights recent developments in instrumental analysis and controlled ice nucleation technology, while also exploring diverse formulation strategies for biologics and vaccines, including plasmid DNA and lipid-based therapeutics.

The chapters are authored by leading experts from academia, industry, and regulatory agencies, ensuring a rich blend of theoretical knowledge and practical experience. With a focus on quality-by-design and process analytical technology approaches, the book includes case studies and insights from the FDA perspective. This makes Lyophilized Biologics and Vaccines an invaluable guide for anyone involved in the development of lyophilized or dehydrated products, from early formulation to regulatory submission and successful product launch.