Development of Biopharmaceutical Drug-Device Products

ForewordJuergen M. Zeidler, PhD and Ramakrishna Venugopalan, PhD (AbbVie)0Part 1: Drug Product Development1Monoclonal Antibodies: Structure, Physicochemical Stability and Protein EngineeringBrittney Mills, Ehab Moussa and Feroz Jameel (AbbVie)12Challenges and Considerations in the Design of Antibody Drug ConjugatesFeroz Jameel, Brittney Mills, Ehab Moussa and Vikram Sisodiya, Anthony Haight and Tony Cano (AbbVie)218Enabling Drug-Device Combination Products: Device-ability in Protein TherapeuticsBernardo Perez-Ramirez, PhD, Jon Kingsbury, and Jifeng Zhang (Sanofi-Genzyme)33Production Strategies and Challenges with IgG-based Bispecific Antibody FormatsChen Gu and Diego Ellerman (Genentech)44Lessons Learned in Understanding Dual-variable Domain Ig (DVD-Ig) Structural Complexity to Select DVD-Ig Lead and Therapeutic CandidatesW. Blaine Stine, Dana Filoti and Tariq Ghayur (AbbVie)56High-Throughput Conformational and Colloidal Stability Screening of Biologic MoleculesPeter M. Ihnat, Jun Zhang, Jianwen Xu and Kan Wu (AbbVie)68An Empirical Phase Diagram/High-Throughput Screening Approach to the Characterization and Formulation of BiopharmaceuticalsRussell Middaugh, Yangje Wei, Sangeet Joshi, Akhilesh Bhambhani, Yuhong Zeng, Nicholas Larson, Gang Hu, Eric Deeds (University of Kansas)79Biophysical Characterization and the Development of Therapeutic ProteinsRussell Middaugh, Yangje Wei, Nicholas Larson, Gang Hu, Prashant Kumar (University of Kansas)85Leveraging the Multi-Attribute Method (MAM) to Improve Biotherapeutic DevelopmentRichard Rogers, PhD (Just Biotherapeutics)97Analytical Methods for Antibody Drug Conjugate CharacterizationStephanie Fischmann, Julie Heflin, Joseph Eschweiler, Beijing Huang, Maike Eisenkolb, Stephanie Katzenbach and Gregory Webster (AbbVie)10 Part 1: Drug Product Development, (continued):Chapter:TitleAuthorsNew #15Particles in Liquid Drug Products: Causes, Characterization and StrategyAnacelia Ríos Quiroz, Miguel Saggu, Jan Olaf Stracke & Jamie Moore (Roche & Genentech)1110Strategies in the Development of Formulations for Antibody based TherapeuticsFeroz Jameel, Ehab Moussa, Brittney Mills and Peter Ihnat (AbbVie)1211Formulation, Drug Product Process and Delivery Considerations for Bi-specific Antibody-Based MoleculesKrishnan Sampathkumar (Macrogenics)
Status TBD1312Formulation Development for Biologics Utilizing Lab Automation and In Vivo Performance ModelsMichael Siedler, Sabine Eichling, Martin Huelsmeyer, and Jonas Angstenberger (AbbVie)1413Practical considerations in high concentration formulation development for monoclonal antibody drug productsDingjiang (Dean) Liu, Quingyan Hu, Bowen Jiang, Xiaolin (Charlie) Tang, Thomas Daly, Mohammed Shameem (Regeneron)1514Drug Product Formulation Robustness Criteria for a MAb in a Pre-filled SyringeKaren Rutherford, Greg Downing and Alvattam Sreedhara (Genentech)1616Development of Robust Lyophilization Process for Therapeutic Proteins: A case StudyEhab Moussa, Tong Zhu and Feroz Jameel (AbbVie)1719Scale-Down Models for Robust Biologics Drug Product Process DevelopmentSmeet Deshmukh, Maria O. Ogunyankin (Merck)1826Design of Clinical in use StudiesSupriya Gupta, Amr Alaarg, Zhen Wu, Xiaofeng Lu, Vivek Garripelli, Hanmin Dong, Stephanie Sawilla, Bhargav Patel, and Rudolf Schroeder, (AbbVie)1920Design of a Bulk Freeze-Thaw Process for BiologicalsFeroz Jameel, Tong Zhu, Ehab Moussa and Brittney Mills (AbbVie)2021Freeze-Thaw Process Analysis and Mechanistic Modeling: Simplified Lumped Capacitance Analysis for Small Fill VolumesAlina A. Alexeenko (Purdue Univ.), Laura Mozdzen, Sherwin Shang, Michelle Long, Grace Kim and Margaret Musser (AbbVie)2125Rational Design of a Freeze-Drying Process for Protein ProductsFeroz Jameel, Tong Zhu, Ehab Moussa and Brittney Mills (AbbVie)2222Development and Scale-up of the Mixing Process for BiopharmaceuticalsFeroz Jameel, Kushal Sinha, Tong Zhu, Nandkishor K. Nere and Ann Czyzewski (AbbVie)23 Part 1: Drug Product Development, (continued):Chapter:TitleAuthorsNew #23Case Study for the Implementation and Utilization of a Technology Platform for Sterile-Grade FiltrationChristine Rinn and Michael Siedler (AbbVie)2424Considerations and Challenges when Filling High-Concentration Monoclonal Antibody Formulations into Pre-filled SyringesWendy Shieu and Yuh-Fun Maa (Genentech)2517Peptide Drug-Device CombinationsShahid Uddin, PhD (AstraZeneca/MedImmune)26Part 2: Drug-Device Combination Products27Development Challenges and Opportunities for Drug/Device Combination ProductsHarold K. Yeager (Yeager Device Solutions, LLC), Mary Roesner Brokovich (Eli Lilly and Company), Michael J. Roe (Kaléo), Paul Jansen (Haselmeier)28Evolving regulatory landscape for Combination Products in the USSuzette Roan (Sanofi), Bonnie Scott and James Boiani (Epstein Becker Green) 29Evolving regulatory landscape for drug/device combination products -- EU and Rest-of-World perspectiveAmanda Matthews (Pfizer-UK), Janine Jamieson (IPQ Publications) and Steve Dew (Biogen)30Importance of Design Control and Risk Management processes in Combination Product DevelopmentHarold K. Yeager (Yeager Device Solutions, LLC), Mary Roesner Brokovich (Eli Lilly and Company), Michael J. Roe (Kaléo), Beat U. Steffen (Confinis)31Standards for Injectable delivery devices:  ISO 11608 series and othersBob Nesbitt (AbbVie), Harold Yeager (Yeager Delivery Solutions, LLC), Mike Roe (Kaléo), Niels Hansen (Novo Nordisk)32Human Factors regulations and standards in combination product development:  IEC 62366 and FDA Guidance documentsMelissa Lemke & Deborah Billing Broky (Agilis Consulting)
33A Science and Risk-based approach to Bridging drug/device combination productsJohn Towns (Lilly)34Design and Development Considerations for Auto-injector Delivery Systems - Technology Developer and Industry PerspectivesLin Laurusonis and Ian Cleathero (AbbVie), Hans Jorgen Jensen (Bespak) Part 2: Drug-Device Combination Products, (continued):Chapter:TitleAuthorsNew #35A case study of bridging from a lyophilizate formulation to an auto injector for patient self-administrationGerard J Bruin and Marie Picci (Novartis), Kenneth Kulmatycki (Ironwood Pharmaceuticals)36On-Market Pre-Filled Syringe and Auto injector StudiesDavid 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 BiologicDon Busby, Kesley Gallagher (Amgen)