Overview
- In depth coverage of lyophilization processes with case studies
- Presents engineering antibodies as therapeutic agents and new FDA requirements
- Includes cyropreservation of biologicals and CFD modeling
Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series (AAPS, volume 59)
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Table of contents (32 chapters)
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Front Matter
Keywords
About this book
Editors and Affiliations
About the editor
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.
Bibliographic Information
Book Title: Principles and Practices of Lyophilization in Product Development and Manufacturing
Editors: Feroz Jameel
Series Title: AAPS Advances in the Pharmaceutical Sciences Series
DOI: https://doi.org/10.1007/978-3-031-12634-5
Publisher: Springer Cham
eBook Packages: Biomedical and Life Sciences, Biomedical and Life Sciences (R0)
Copyright Information: America Association of Pharmaceutical Scientists 2023
Hardcover ISBN: 978-3-031-12633-8Published: 25 April 2023
Softcover ISBN: 978-3-031-12636-9Due: 09 September 2023
eBook ISBN: 978-3-031-12634-5Published: 24 April 2023
Series ISSN: 2210-7371
Series E-ISSN: 2210-738X
Edition Number: 1
Number of Pages: XIII, 623
Topics: Pharmacy, Pharmaceutical Sciences/Technology, Pharmacology/Toxicology, Biomedicine, general