Principles and Practices of Lyophilization in Product Development and Manufacturing

Buch | Hardcover

XIII, 623 Seiten

2023 | 2023
Springer International Publishing (Verlag)
978-3-031-12633-8 (ISBN)

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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), Chimeric Antigen Receptor - Modified Tcells (CART) that are currently being used as therapeutic agents for immunology and oncology disease conditions. In addition to other pharmaceuticals and biopharmaceuticals, all these novel formats are fragile with respect to their stability/structure under processing conditions meaning marginal stability in the liquid state and often require lyophilization to enhance their stability and shelf-life. This book contains chapters/topics that will describe every aspect of the lyophilization process and product development and manufacturing starting from the overview of lyophilization process, equipment required, characterization of the material, design and development of the formulation and lyophilization process, various techniques for characterization of the product, scale-up/tech-transfer and validation. It also describes the application of CFD coupled with mathematical modeling in the lyophilization process and product development, scale-up, and manufacturing. Additionally, Principles and Practice of Lyophilization Process and Product Development contains an entire dedicated section on "Preservation of Biologicals" comprised of nine chapters written by experts and including case studies.

Feroz Jameel is a group leader in Formulation and Process Development for New Biological Entities at AbbVie, in Lake County, IL, where he is involved in the formulation and process development, optimization, scale-up and transfer to manufacturing of biopharmaceutical products. Feroz received his Master's degree in Pharmaceutics from the University of Delhi and Ph.D in Pharmaceutics (Pharmaceutical Sciences) from the University of Connecticut. His publications include over 20 peer-reviewed manuscripts, over 20 presentations, and several book chapters. He is the co-editor of the books "Formulation and Process Development Strategies for Manufacturing of Biopharmaceuticals" and "Quality by Design for Biopharmaceutical Drug Product Development". He has held several leadership positions at the AAPS including chair of "Freezing and Drying Technologies" and led the industrial consortium for Lyo QbD. He is a recipient of 2 patents in lyophilization formulation and lyophiliztion process development. Feroz received several awards including the AAPS and PDA's Fred Simon's award for the best paper published in the PDA Journal of Pharmaceutical Science and Technology. He has also chaired several symposia on the development of biological products.

Overview of Freeze Drying .- Characterization and Determination of Freeze Drying Properties of Frozen Formulations - Case Studies.- Beyond pH: Acid/base relationships in frozen and freeze-dried pharmaceuticals.- Concepts and Strategies in the Design of Formulation for Freeze Drying.- Formulation Design for Freeze Drying - Case studies of Stabilization of Proteins.- Challenges and Considerations in the Development of a High Protein Concentration Lyophilized Drug Product.- Freeze-drying of thermosensible pharmaceuticals with organic co-solvent + water formulations.- Primary container closure system selection for lyophilized drug products.- Vial Breakage During Lyophilization.- The Nucleation of Ice.- Stresses, Stabilization, and Recent Insights in Freezing of Biologics.- Lyophilization Process Understanding and Scale-up using ab initio Vial Heat Transfer Modeling.- Secondary drying: Challenges and Considerations.- Design and Process Considerationsin Spray Freeze Drying.- LyoPRONTO: Deterministic and Probabilistic Modeling. Tutorial and Case Study.- Utilizing Solid-State NMR Spectroscopy to Assess Properties of Lyophilized Formulations.- Design of Moisture Studies for a Lyophilized Product.- Laser-Based Headspace Moisture Analysis for Rapid Nondestructive Moisture Determination of Lyophilized Products.- Application of PAT in Real-time Monitoring and Controlling of Lyophilization Process.- Process Analytical Technology (PAT) for Lyophilization Process Monitoring and End Point Detection.- Advances in Process Analytical Technology - A Small Scale Freeze-Dryer for Process Analysis, Optimization, and Transfer.- Overview of Heat and Mass Transfer Modeling in Lyophilization to Create Design Spaces and Improve Process Analytical Tool (PAT) Capability.- Application of QbD elements in the Development and Manufacturing of a Lyophilized product.- Characterization of Freeze Dryer.- Scale-up and Technology Transfer of a Lyophilization Process.- Lyophilization Validation: Process Design and Modeling.- Lyophilization Validation: Process Qualification and Continued Process Verification.- Homogeneity Assessment of Lyohilized Biological Drug Products During Process Performance Qualification.- Informed Manufacturing through the use of Big Data Analytics for Freeze Drying Process & Equipment.- Multivariate Analysis for Process Understanding, Continuous Process Verification and Condition Monitoring of Lyophilization Processes.- Lyophilized Drug Product Cake Appearance: What Is Acceptable?.

Erscheinungsdatum	28.04.2023
Reihe/Serie	AAPS Advances in the Pharmaceutical Sciences Series
Zusatzinfo	XIII, 623 p.
Verlagsort	Cham
Sprache	englisch
Maße	210 x 279 mm
Gewicht	1789 g
Themenwelt	Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
	Medizin / Pharmazie ► Pflege
	Medizin / Pharmazie ► Pharmazie ► PTA / PKA
	Technik
Schlagworte	Antibody drug conjugates • Biologics • biopharmaceuticals • BITES (Bispecific T Cell ) • CART (chimeric antigen receptor modified T-Cell) • cryopreservation of pharmaceuticals • drying technologies pharmaceutical sciences • freeze drying pharmaceuticals • QBD • scale up pharmaceutical processes
ISBN-10	3-031-12633-5 / 3031126335
ISBN-13	978-3-031-12633-8 / 9783031126338
Zustand	Neuware