This reference describes applications of computational and molecular modeling techniques toward more efficient and affordable biopharmaceutical drug development at the pre-clinical stages that could positively impact clinical outcomes. With a primary focus on the developability of monoclonal antibody candidates, it addresses many contributions that computation can make towards biopharmaceutical drug development in general. It is a rich source of information on current principles and practices and provides a starting point for finding innovative applications of computation in biotherapeutics.

PRINCIPLES OF BIOPHARMACEUTICAL INFORMATICS. Biopharmaceutical Informatics: Applications of Computation in Biologic Drug Development. Computational Methods in the Optimization of Biologic Modalities. Understanding, Predicting, and Mitigating the Impact of Posttranslational Physiochemical Modifications, Including Aggregation, on the Stability of Biopharmaceutical Drug Products. Preclinical Immunogenicity Risk Assessment of Biotherapeutics. Application of Mechanistic Pharmacokinetic-Pharmacodynamic Modeling toward the Development of Biologics. Challenges in High-Concentration Biopharmaceutical Drug Delivery: A Modeling Perspective. DEVELOPABILITY PRACTICES IN THE BIOPHARMACEUTICAL INDUSTRY. Best Practices in Assessment of Developability of Biopharmaceutical Candidates. Best Practices in Developability Assessments of Therapeutic Protein Candidates in the Biopharmaceutical Industry. Best Practices in Assessing the Developability of Biopharmaceutical Candidates. Developability Assessment Workflows to De-Risk Biopharmaceutical Development.