Main description:

The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and process based on sound science. Drug delivery systems have become an increasingly important part of the therapy and most biopharmaceuticals for self-administration are being marketed as combination products. A survey of the market indicates that there is a strong need for a new book that will provide "one stop shopping" for the latest information and knowledge of the scientific and engineering advances made over the last few years in the area of biopharmaceutical product development. The new book entitled Development of Biopharmaceutical Drug Device Products is a reference text for scientists and engineers in the biopharmaceutical industry, academia or regulatory agencies. With insightful chapters from experts in the field, this new book reviews first principles, covers recent technological advancements and provides case studies and regulatory strategies relating to the development and manufacture of antibody-based products. It covers topics such as the importance of early preformulation studies during drug discovery to influence molecular selection for development, formulation strategies for new modalities, and the analytical techniques used to characterize them. It also addresses important considerations for later stage development such as the development of robust formulations and processes, including process engineering and modeling of manufacturing unit operations, the design of analytical comparability studies, and characterization of primary containers (pre-filled syringes and vials).Finally, the latter half of the book reviews key considerations to ensure the development and approval of a patient-centered delivery system design. This involves the evolving regulatory framework with perspectives from both the US and EU industry experts, the role of international standards, design control/risk management, human factors and its importance in the product development and regulatory approval process, as well as review of the risk-based approach to bridging between devices used in clinical trials and the to-be-marketed device. Finally, case studies are provided throughout.The typical readership would have biology and/or engineering degrees and would include researchers, scientific leaders, industry specialists and technology developers working in the biopharmaceutical field.

Contents:

Foreword Juergen M. Zeidler, PhD and Ramakrishna Venugopalan, PhD (AbbVie) 0Part 1: Drug Product Development1 Monoclonal Antibodies: Structure, Physicochemical Stability and Protein Engineering Brittney Mills, Ehab Moussa and Feroz Jameel (AbbVie) 12 Challenges and Considerations in the Design of Antibody Drug Conjugates Feroz Jameel, Brittney Mills, Ehab Moussa and Vikram Sisodiya, Anthony Haight and Tony Cano (AbbVie) 218 Enabling Drug-Device Combination Products: Device-ability in Protein Therapeutics Bernardo Perez-Ramirez, PhD, Jon Kingsbury, and Jifeng Zhang (Sanofi-Genzyme) 33 Production Strategies and Challenges with IgG-based Bispecific Antibody Formats Chen Gu and Diego Ellerman (Genentech) 44 Lessons Learned in Understanding Dual-variable Domain Ig (DVD-Ig) Structural Complexity to Select DVD-Ig Lead and Therapeutic Candidates W. Blaine Stine, Dana Filoti and Tariq Ghayur (AbbVie) 56 High-Throughput Conformational and Colloidal Stability Screening of Biologic Molecules Peter M. Ihnat, Jun Zhang, Jianwen Xu and Kan Wu (AbbVie) 68 An Empirical Phase Diagram/High-Throughput Screening Approach to the Characterization and Formulation of Biopharmaceuticals Russell Middaugh, Yangje Wei, Sangeet Joshi, Akhilesh Bhambhani, Yuhong Zeng, Nicholas Larson, Gang Hu, Eric Deeds (University of Kansas) 79 Biophysical Characterization and the Development of Therapeutic Proteins Russell Middaugh, Yangje Wei, Nicholas Larson, Gang Hu, Prashant Kumar (University of Kansas) 85 Leveraging the Multi-Attribute Method (MAM) to Improve Biotherapeutic Development Richard Rogers, PhD (Just Biotherapeutics) 97 Analytical Methods for Antibody Drug Conjugate Characterization Stephanie Fischmann, Julie Heflin, Joseph Eschweiler, Beijing Huang, Maike Eisenkolb, Stephanie Katzenbach and Gregory Webster (AbbVie) 10 Part 1: Drug Product Development, (continued):Chapter: Title Authors New #15 Particles in Liquid Drug Products: Causes, Characterization and Strategy Anacelia Rios Quiroz, Miguel Saggu, Jan Olaf Stracke & Jamie Moore (Roche & Genentech) 1110 Strategies in the Development of Formulations for Antibody based Therapeutics Feroz Jameel, Ehab Moussa, Brittney Mills and Peter Ihnat (AbbVie) 1211 Formulation, Drug Product Process and Delivery Considerations for Bi-specific Antibody-Based Molecules Krishnan Sampathkumar (Macrogenics)
Status TBD 1312 Formulation Development for Biologics Utilizing Lab Automation and In Vivo Performance Models Michael Siedler, Sabine Eichling, Martin Huelsmeyer, and Jonas Angstenberger (AbbVie) 1413 Practical considerations in high concentration formulation development for monoclonal antibody drug products Dingjiang (Dean) Liu, Quingyan Hu, Bowen Jiang, Xiaolin (Charlie) Tang, Thomas Daly, Mohammed Shameem (Regeneron) 1514 Drug Product Formulation Robustness Criteria for a MAb in a Pre-filled Syringe Karen Rutherford, Greg Downing and Alvattam Sreedhara (Genentech) 1616 Development of Robust Lyophilization Process for Therapeutic Proteins: A case Study Ehab Moussa, Tong Zhu and Feroz Jameel (AbbVie) 1719 Scale-Down Models for Robust Biologics Drug Product Process Development Smeet Deshmukh, Maria O. Ogunyankin (Merck) 1826 Design of Clinical in use Studies Supriya Gupta, Amr Alaarg, Zhen Wu, Xiaofeng Lu, Vivek Garripelli, Hanmin Dong, Stephanie Sawilla, Bhargav Patel, and Rudolf Schroeder, (AbbVie) 1920 Design of a Bulk Freeze-Thaw Process for Biologicals Feroz Jameel, Tong Zhu, Ehab Moussa and Brittney Mills (AbbVie) 2021 Freeze-Thaw Process Analysis and Mechanistic Modeling: Simplified Lumped Capacitance Analysis for Small Fill Volumes Alina A. Alexeenko (Purdue Univ.), Laura Mozdzen, Sherwin Shang, Michelle Long, Grace Kim and Margaret Musser (AbbVie) 2125 Rational Design of a Freeze-Drying Process for Protein Products Feroz Jameel, Tong Zhu, Ehab Moussa and Brittney Mills (AbbVie) 2222 Development and Scale-up of the Mixing Process for Biopharmaceuticals Feroz Jameel, Kushal Sinha, Tong Zhu, Nandkishor K. Nere and Ann Czyzewski (AbbVie) 23 Part 1: Drug Product Development, (continued):Chapter: Title Authors New #23 Case Study for the Implementation and Utilization of a Technology Platform for Sterile-Grade Filtration Christine Rinn and Michael Siedler (AbbVie) 2424 Considerations and Challenges when Filling High-Concentration Monoclonal Antibody Formulations into Pre-filled Syringes Wendy Shieu and Yuh-Fun Maa (Genentech) 2517 Peptide Drug-Device Combinations Shahid Uddin, PhD (AstraZeneca/MedImmune) 26Part 2: Drug-Device Combination Products27 Development Challenges and Opportunities for Drug/Device Combination Products Harold K. Yeager (Yeager Device Solutions, LLC), Mary Roesner Brokovich (Eli Lilly and Company), Michael J. Roe (Kaleo), Paul Jansen (Haselmeier) 28 Evolving regulatory landscape for Combination Products in the US Suzette Roan (Sanofi), Bonnie Scott and James Boiani (Epstein Becker Green) 29Evolving regulatory landscape for drug/device combination products -- EU and Rest-of-World perspective Amanda Matthews (Pfizer-UK), Janine Jamieson (IPQ Publications) and Steve Dew (Biogen) 30 Importance of Design Control and Risk Management processes in Combination Product Development Harold K. Yeager (Yeager Device Solutions, LLC), Mary Roesner Brokovich (Eli Lilly and Company), Michael J. Roe (Kaleo), Beat U. Steffen (Confinis) 31 Standards for Injectable delivery devices: ISO 11608 series and others Bob Nesbitt (AbbVie), Harold Yeager (Yeager Delivery Solutions, LLC), Mike Roe (Kaleo), Niels Hansen (Novo Nordisk) 32Human Factors regulations and standards in combination product development: IEC 62366 and FDA Guidance documents Melissa Lemke & Deborah Billing Broky (Agilis Consulting)
33 A Science and Risk-based approach to Bridging drug/device combination products John Towns (Lilly) 34 Design and Development Considerations for Auto-injector Delivery Systems - Technology Developer and Industry Perspectives Lin Laurusonis and Ian Cleathero (AbbVie), Hans Jorgen Jensen (Bespak) Part 2: Drug-Device Combination Products, (continued):Chapter: Title Authors New #35A case study of bridging from a lyophilizate formulation to an auto injector for patient self-administration Gerard J Bruin and Marie Picci (Novartis), Kenneth Kulmatycki (Ironwood Pharmaceuticals) 36 On-Market Pre-Filled Syringe and Auto injector Studies David A. Post, Sherwin Shang, Shweta A. Raina and William Szechinski (AbbVie) 37Considerations in the Development, Approval and Commercialization of On-Body Delivery Devices Used in Combination with a Biologic Don Busby, Kesley Gallagher (Amgen)