Biopharmaceuticals are emerging as frontline medicines to combat several life-threatening and chronic diseases. However, such medicines are expensive to develop and produce on a commercial scale, contributing to rising healthcare costs. Developability of Biotherapeutics: Computational Approaches describes applications of computational and molecular modeling techniques that improve the overall process of discovery and development by removing empiricism.
The concept of developability involves making rational choices at the pre-clinical stages of biopharmaceutical drug development that could positively impact clinical outcomes. The book also addresses a general lack of awareness of the many different contributions that computation can make to biopharmaceutical drug development.
This informative and practical reference is a valuable resource for professionals engaged in industrial research and development, scientists working with regulatory agencies, and pharmacy, medicine, and life science students and educators. It focuses primarily on the developability of monoclonal antibody candidates, but the principles described can also be extended to other modalities such as recombinant proteins, fusion proteins, antibody drug conjugates and vaccines.
The book is organized into two sections. The first discusses principles and applications of computational approaches toward discovering and developing biopharmaceutical drugs. The second presents best practices in developability assessments of early-stage biopharmaceutical drug candidates.
In addition to raising awareness of the promise of computational research, this book also discusses solutions required to improve the success rate of translating biologic drug candidates into products available in the clinic. As such, it is a rich source of information on current principles and practices as well as a starting point for finding innovative applications of computation towards biopharmaceutical drug development.
‘Developability of Biotherapeutics: Computational Approaches presents the most extensive and systematic overview to date, of modern computational approaches that are being used industrially to assess potential manufacturability and overall ease of development of biotherapeutics such as monoclonal antibodies. The book covers a wide array of topics, spanning from immunogenicity and pharmacokinetic/dynamic properties to key chemical and physical stability attributes. It is recommended as important reading for researchers from both academic and industrial perspectives, and will be of particular interest for graduate students seeking to gain an experienced perspective of the current state of the art and opportunities for high impact research in the future’.
– Christopher J. Roberts, Professor of Chemical & Biomolecular Engineering, University of Delaware.
'Developability of Biotherapeutics: computational approaches presents a state-of-the art and modern overview on computational approaches for evaluating developability of biotherapeutics. Optimal molecule design and selection is a yet underappreciated and underutilized element of finding, developing, and finally commercializing the best molecule. The optimum molecule not only serves patient needs by ensuring efficacy and safety, but is also optimized from a technical drug product development perspective. This book is a must-read for industrial and academic researchers involved in discovering, identifying and optimizing molecules and transitioning from research to development and beyond.'
– Prof. Dr. Hanns-Christian Mahler, Head of Drug Product Services, Lonza AG.
‘This book represents a compelling opening salvo to the field of computational methods applied to antibody developability. The chapters are… supported by extensive and timely literature citations: the average number of citations per chapter goes above 90, with over 50% of the references dating to 2009 or later. Developability of Biotherapeutics: Computational Approaches should be a good addition to the libraries of industrial and academic groups engaged in, or supporting, development of biopharmaceutical drugs.’
– Charlotte M. Deane & Maximiliano Vásquez (2016), mAbs, DOI: 10.1080/19420862.2016.1256723.
PRINCIPLES OF BIOPHARMACEUTICAL INFORMATICS
Biopharmaceutical Informatics: Applications of Computation in Biologic Drug Development
Sandeep Kumar, Russell H. Robins, Patrick M. Buck, Timothy P. Hickling, A. Mary Thangakani, Li Li, Satish K. Singh, and M. Michael Gromiha
Computational Methods in the Optimization of Biologic Modalities
Surjit B. Dixit
Understanding, Predicting, and Mitigating the Impact of Posttranslational Physiochemical Modifications, Including Aggregation, on the Stability of Biopharmaceutical Drug Products
Neeraj J. Agrawal and Naresh Chennamsetty
Preclinical Immunogenicity Risk Assessment of Biotherapeutics
Tim D. Jones, Anette C. Karle, and Matthew P. Baker
Application of Mechanistic Pharmacokinetic–Pharmacodynamic Modeling toward the Development of Biologics
Pratap Singh, Abhinav Tiwari, Anson K. Abraham, and Anup Zutshi
Challenges in High-Concentration Biopharmaceutical Drug Delivery: A Modeling Perspective
DEVELOPABILITY PRACTICES IN THE BIOPHARMACEUTICAL INDUSTRY
Best Practices in Assessment of Developability in Biopharmaceutical Candidates
Steffen Hartmann and Hans P. Kocher
Best Practices in Developability Assessments of Therapeutic Protein Candidates in the Biopharmaceutical Industry
Nicolas Angell, Randal R. Ketchem, Kristine Daris, Jason W. O’Neill, and Kannan Gunasekaran
Best Practices in Assessing the Developability of Biopharmaceutical Candidates
Juan C. Almagro and Alessandro Mascioni
Developability Assessment Workflows to De-Risk Biopharmaceutical Development
Jesús Zurdo, Andreas Arnell, Olga Obrezanova, Noel Smith, Thomas R. A. Gallagher, Ramón Gómez de la Cuesta, and Ben Locwin