Details

Subject(s)

• Cellular therapy—Handbooks, manuals, etc [Browse]
• Gene therapy—Handbooks, manuals, etc [Browse]
• Cellular therapy—Research—Handbooks, manuals, etc [Browse]
• Gene therapy—Research—Handbooks, manuals, etc [Browse]

Editor

• Aranha, Hazel G. [Browse]
• Vega-Mercado, Humberto [Browse]

Biographical/​Historical note

Dr. Hazel Aranha Dr Hazel Aranha is a biopharma professional with over 35 years' experience in industry, academia and consulting. She is a subject matter expert in the area of adventitious agent contamination in biopharmaceuticals and cell and gene therapy products. Her company, Gaea Resources Inc, has provided consulting and auditing services in the US, Europe, and Asia. Hazel brings deep domain expertise to assist clients in achieving strategic and operational objectives. Her projects have included opportunity mapping and competitive market analysis, due diligence for potential acquisitions, and gap analysis to identify key risks and propose mitigation strategies. She has conducted customized training to address unmet needs in the biopharma sector. Hazel has a Master's degree in Virology, Ph.D. in Environmental Microbiology and holds Regulatory Affairs Certification (RAC) for both the US and European Union. She has to her credit 2 books, more than 45 publications, and 5 book chapters. She is on the review board of multiple biotechnology journals. Her past assignments have included positions at Sartorius Stedim N.A., Catalent Pharma Solutions, Wyeth Vaccines (Pfizer), and Pall Corporation. She holds professional memberships in the Parenteral Drug Association (PDA) and Regulatory Affairs Professional Society (RAPS). Dr. Humberto Vega-Mercado Affiliation: Bristol Myers Squibb, Cell Therapy Operations, Global Manufacturing Sciences and Technology Dr. Humberto Vega is Sr. Director of BMS., Cell Therapy Operations, Global Manufacturing Sciences and Technology (GMS&T), Head of External Manufacturing Drug Product, Critical Materials, Packaging Technology, Labeling, Cell Therapy Capability Center, Apheresis, and Non-Cell Products Technical Groups based in Summit NJ. He has been in the pharmaceutical and food industries for over 34 years in multiple roles including Research Assistant-Food Processing, Process and Manufacturing Head of sterile and non-sterile pharmaceutical operations, Sr. Scientist and Associate Director of Validation, Technology Head - Vaccine Technology and Engineering, Associate Director of MS&T, and Sr. Director of MS&T. He holds BS and MS degrees in chemical engineering from the University of Puerto Rico and a PhD in engineering science from Washington State University. He holds professional memberships in the Parenteral Drug Association (PDA), Institute of Food Technologists (IFT) and International Society for Pharmaceutical Engineering (ISPE).

Summary note

"This handbook provides an in-depth review of information across the developmental spectrum of gene and cell therapy products. From introductory information to state-of-the-art technologies and concepts, the book provides insights into upstream processes such as vector design and construction, purification, formulation and fill/finish as well as delivery options. Planning steps for compliance with current good manufacturing practice (CGMP) to readiness for chemistry, manufacturing, and controls (CMC) are also discussed. This book wraps up with examples of successes and pitfalls addressed by experts who have navigated the multiple challenges that are part of any innovative endeavor"-- Provided by publisher.

Bibliographic references

Includes bibliographical references and index.

Source of description

Description based on print version record and CIP data provided by publisher; resource not viewed.

ISBN

• 1000864200 ((electronic bk. : PDF))
• 1000864251 ((electronic bk. : EPUB))
• 1003285066
• 9781000864205 ((electronic bk. : PDF))
• 9781000864250 ((electronic bk. : EPUB))
• 9781003285069 ((ebook))

LCCN

2022050143

OCLC

1371485068

Doi

• 10.1201/9781003285069

Statement on language in description

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