Biotechnology for Pharmaceutical Sciences Concepts and Applications

This book provides a compact and straightforward overview of the main concepts and applications of Pharmaceutical Biotechnology. The author collates lecture notes on Pharmaceutical Biotechnology to introduce the topic to graduate students in the fields of Pharmaceutical Sciences, Biochemistry, Biotechnology and Industrial Biotechnology, Microbiology, and Medicinal Chemistry.

The book starts with an overview of the biotechnological processes needed to develop biological and biosimilar medicines. Next, the author addresses the development and use of advanced therapy medicinal products (ATMPs), including topics such as cell and gene therapies, regenerative medicine and the regulatory issues of biological medicines and ATMPs. Finally, the author explores the limitations of administering biopharmaceuticals, discussing protein and nucleic acid stability issues, potential routes of administration and strategies for improving the bioavailability of biologics and ATMPs.

This book captures the latest developments in the field and offers a practical perspective on the topic, serving as a valuable introduction resource not only for graduate students but also for researchers.

The basis of the English translation of this book, originally in Portuguese, was facilitated by artificial intelligence. The content was later revised by the author for accuracy.

General Concepts.- Fundamentals of molecular Biotechnology.- Genetic expression.- Bioprocesses.- Biologicals.- Classes of biologicals.- Cell therapy.- Nucleic acids-based therapies.- Genomic and pharmacogenomic.- Regulatory issues.- Administration of biologicals.

Ana Catarina Silva is an Associate Professor of Pharmaceutical Technology and Pharmaceutical Biotechnology and Researcher at FP-I3ID, FP-BHS, Faculty of Health Sciences, University Fernando Pessoa, Porto, Portugal; and Senior Researcher at UCIBIO, Faculty of Pharmacy, University of Porto, Portugal. She has a European PhD in Pharmaceutical Sciences with specialization in Pharmaceutical Technology from the University of Porto; and a Graduation in Pharmaceutical Sciences from the University Fernando Pessoa, Porto, Portugal. Professor Silva is also the author of several works in the areas of Pharmaceutical Technology and Pharmaceutical Biotechnology (h-index of 25) with 55+ articles, 6 book chapters, 50+ posters, and 15 oral communications. She also edited 6 books in this field; and acted as invited editor of 12 special issues. Professor Silva was included in the World's Top 2% Scientists List, in 2021, 2022 and 2023, by Stanford University, USA, and served as a referee for 10+ international funding agencies and 50+ international scientific journals. She is also a member of the editorial board of the Springer book series: Advances in Biochemical Engineering/Biotechnology; and the journals Dermatological Drug Delivery from Frontiers in Drug Delivery; Chinese Chemical Letters; Current Drug Metabolism; and Biochemistry & Pharmacology: Open Access. She supervises of 6 PhD students (2 completed), 6 MSc students (5 completed), and 37 undergraduate students (34 completed). Her current research interests are focused on developing lipid-based nanosystems to improve drug delivery. In particular, nose-to-brain delivery and cutaneous delivery; the quality-by-design (QbD) approach to optimize formulations of lipid-based nanosystems; and the development of Biopharmaceuticals and Advanced Therapy Medicinal Products (ATMPs).