Nonclinical Development of Biologics, Biosimilars, Vaccines and Specialty Biologics, Second Edition is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies, and blood products. Updated and revised, the new edition compares and contrasts these types of biologics with one another, and with small molecule drugs while incorporating the most current and essential international regulatory guidelines. Each section discusses a different type of biologic, as well as early characterization strategies, principles of study design, preclinical pharmacokinetics and pharmacodynamics and preclinical assays. This multi-edited book with chapters authored by leading qualified experts in the field offers a comprehensive reference on critical insights that will be of interest to researchers involved in early through late-stage biologics.

• Provides in-depth coverage of the process of nonclinical safety assessment and comprehensive reviews of each type of biopharmaceutical
• Contains the most pertinent international regulatory guidance documents for nonclinical evaluation
• Covers early de-risking strategies and designs of safety assessment programs for novel biopharmaceuticals and vaccines, as well as follow-on biologics or "biosimilars"
• Updated and revised, with new chapters on nonclinical development of monovalent and polyvalent biopharmaceuticals; pharmacokinetics, pharmacodynamics, and bioanalytics; regulatory expectations and early characterization of biosimilar therapeutics; and cell and gene therapies