Principles and Practices of Lyophilization in Product Development and Manufacturing

ISBN-13: 9783031126338 / Angielski / Twarda / 2023 / 242 str.

Feroz Jameel

Opis

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.

Spis treści

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

After graduating from University of Connecticut with a Ph.D in Pharmaceutical sciences, Feroz started his carrier with  Baxter Biosciences where he was involved in the end-to-end development and tech transfer of lyophilized dosage form of recombinant Factor VIII (RecombinateTM). In 2002, Feroz joined Amgen where he had the opportunity to work on all aspects of drug product development and manufacturing of various modalities including Enbrel®, Nplate®, Repatha® and Blincyto®.  In 2016 Feroz joined AbbVie heading the formulation development function of New Biological Entities, Lake County, IL, where he was involved in early and late-stage development of parenteral products. Feroz joined Gilead sciences in January 2021 and was the Director and head of the commercial drug product and formulation.  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”, “Quality by Design for Biopharmaceutical Drug Product Development” and “Development of Biopharmaceutical Drug Device Products”. He has held several leadership positions at the AAPS including chair of “Freezing and Drying Technologies” and led the industrial consortium for Lyo QbD.  Recently, he led the industrial consortium on “Best practices/guidelines for validation of Lyophilization process and products” and published 2 papers. He is a recipient of 2 patents in lyophilization formulation and lyophilization process development. In addition to corporate awards, Henry Kramer from Baxter and Volwiler Award from AbbVie, 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.