Principles and Practices of Lyophilization in Product Development and Manufacturing
Springer International Publishing (Verlag)
978-3-031-12636-9 (ISBN)
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.
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 | 23.04.2024 |
|---|---|
| Reihe/Serie | AAPS Advances in the Pharmaceutical Sciences Series |
| Zusatzinfo | XIII, 623 p. |
| Verlagsort | Cham |
| Sprache | englisch |
| Maße | 210 x 279 mm |
| Themenwelt | Medizin / Pharmazie ► Pharmazie ► PTA / PKA |
| 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 | 3-031-12636-X / 303112636X |
| ISBN-13 | 978-3-031-12636-9 / 9783031126369 |
| Zustand | Neuware |
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