Challenges in Protein Product Development

Description

In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration, solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies. Front Matter ....Pages i-xvi Front Matter ....Pages 1-1 Introduction into Formulation Development of Biologics (Daniel Weinbuch, Andrea Hawe, Wim Jiskoot, Wolfgang Friess)....Pages 3-22 Front Matter ....Pages 23-23 Polysorbate Degradation and Quality (Kishore S. K. Ravuri)....Pages 25-62 Sucrose and Trehalose in Therapeutic Protein Formulations (Satish K. Singh)....Pages 63-95 Front Matter ....Pages 97-97 Introduction to High-Concentration Proteins (Wei Wang, Arun Alphonse Ignatius, Satoshi Ohtake, Teng-Chieh Yang)....Pages 99-123 Solubility, Opalescence, and Particulate Matter (Hanns-Christian Mahler, Anja Matter)....Pages 125-137 Analytical Characterization and Predictive Tools for Highly Concentrated Protein Formulations (Andrea Allmendinger, Stefan Fischer, Robert Mueller)....Pages 139-161 Practical Considerations for High Concentration Protein Formulations (Deirdre Murphy Piedmonte, Jian Hua Gu, Stephen R. Brych, Monica M. Goss)....Pages 163-187 Front Matter ....Pages 189-189 Parenteral Container Closure Systems (Roman Mathaes, Alexander Streubel)....Pages 191-202 Development of Prefilled Syringe Combination Products for Biologics (Mariana N. Dimitrova, Jared S. Bee, Ling Lu, Jason E. Fernandez)....Pages 203-224 Special Topics in Analytics of Pre-filled Syringes (Atanas Koulov)....Pages 225-233 C Mini-pumps (Dirk Gläser, Jürg Liniger, Daniel Peter)....Pages 235-256 Container Closure Integrity Testing of Primary Containers for Parenteral Products (Shu-Chen Chen)....Pages 257-290 Chemical Durability of Glass—Delamination (Holger Roehl, Philippe Lam, Dominique Ditter)....Pages 291-304 Fogging (Holger Roehl, Philippe Lam, Dominique Ditter)....Pages 305-309 Front Matter ....Pages 311-311 Bulk Protein Solution: Freeze–Thaw Process, Storage and Shipping Considerations (Parag Kolhe, Sumit Goswami)....Pages 313-336 Leachables and Extractables: From Regulatory Expectations to Laboratory Assessment (Michael Jahn)....Pages 337-351 Biotherapeutic Drug Product Manufacturing and Process Development (Daniel Dixon, Anthony Gudinas)....Pages 353-383 Line Sterilization Considerations and VHP (Ulla Grauschopf, Katherine Thomas, Joerg Luemkemann, Sebastian Schneider, Ada Hui, Y. John Wang et al.)....Pages 385-406 Lyophilization: Process Design, Robustness, and Risk Management (Daniel Dixon, Serguei Tchessalov, Bakul Bhatnagar)....Pages 407-439 Scientific Approaches for the Application of QbD Principles in Lyophilization Process Development (Vinay Radhakrishnan, Penny Davis, David Hiebert)....Pages 441-471 Manufacturing of Highly Potent Drug Product in a Clinical Multi-Product Aseptic Facility and Transfer of Principles to Antibiotic Drug Product (Karoline Bechtold-Peters, Silke Mohl)....Pages 473-493 Front Matter ....Pages 495-495 Introduction into Novel Constructs (Susanne Joerg, Kapil Gupta, Margarida Rodrigues)....Pages 497-526 Novel Constructs—Half-Life Extensions (Jeonghoon Sun, Mark Michaels)....Pages 527-544 “Fc Fusion Proteins” (Carole Heath, Dean Pettit)....Pages 545-558 Front Matter ....Pages 559-559 Lifecycle Management of Biotherapeutic Dosage Forms (Nicholas Warne, Bryan Balthazor, William Parr)....Pages 561-578 Switching from an IV to an SC Formulation—Considerations for Formulation Development and Formulation Bridging (Claudia Mueller, Michael Adler)....Pages 579-590 Back Matter ....Pages 591-599