BIO09065 2019 Formulation and Delivery of Biopharmaceuticals

This module deals with advanced methods of biopharmaceutical formulation and finish for stable drug delivery. It aims to provide students with a critical overview of the challenges faced in the formulation and administration of biopharmaceuticals and the strategies being adopted to overcome these barriers. The latest advances for successful formulation and delivery of biologic drugs will be described. 

"Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition" addresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics and cost-effectiveness considerations. The new edition also provides an update on new proteins and genetic medicines, the translational and integrated sciences that continue to fuel the innovations in medicine, as well as the new areas of therapeutic development including cancer vaccines, stem cell therapeutics, and cell-based therapies.

A comprehensive textbook covering the design of dosage forms and all aspects of drug delivery systems. 'Pharmaceutics' in its broadest sense is the 'art of the apothecary' or, in simple terms, pharmaceutical preparations. It remains a diverse subject in the pharmacy curriculum, encompassing design of drugs, their manufacture, and the elimination of micro-organisms from the products. This books encompasses all those areas and pays particular attention to the design of dosage forms and their manufacture.

There are more than 500 biopharmaceuticals on the market, including more than 200 therapeutic proteins, making biologics the fastest growing sector in the biopharmaceutical market. These products include more than 40 monoclonal antibodies, for indications ranging from treatment or mitigation of various types of cancer to rheumatoid arthritis. The clinical application of these therapeutic peptides and proteins is limited by several problems, such as lack of physical and chemical stability or the lack of desirable attributes for adequate absorption or distribution. Thus, as these therapeutic peptides and proteins are made available, it will be essential to formulate these drugs into safe, stable, and efficacious delivery systems. The pharmaceutical scientist involved in this effort needs to call upon the knowledge of several disciplines, such as pharmaceutics, medicinal chemistry, biochemistry, microbiology, and chemical engineering and needs to keep abreast with the latest research in the published literature. Therapeutic Peptides and Proteins: Formulation, Processing, and Delivery Systems, Third Edition provides a comprehensive overview of the field for scientists in industry and academia and for students, while also providing practical information on the challenges facing the formulation and delivery aspects of these unique macromolecules. In particular, the book: Explains how recombinant DNA techniques now allow us to produce therapeutic proteins in a commercially viable form Discusses the physical and chemical pathways of peptide and protein degradation Includes a detailed discussion of protein formulation and lyophilization Overviews the pharmacokinetic aspects of therapeutic peptides and proteins and discusses controlled delivery systems for parenteral administration, including microsphere formulations Discusses research progress on oral, transdermal, mucosal, and topical delivery systems discusses transdermal and topical delivery

Advances in biotechnology have provided scientists with anincreasing number of biopharmaceuticals such as novel peptide andprotein drugs as well as nucleic acid based drugs for gene therapy.However, successful delivery of these biopharmaceuticals is a majorchallenge because their molecular properties lead to poor physicaland chemical stability in the body and limited membranepermeability. Therefore researchers are developing a range of newdelivery technologies and materials to enable these new drugs to bedelivered intact to their target sites. Delivery Technologies forBiopharmaceuticals describes strategies to overcome themain barriers for successful delivery of therapeutic peptides,proteins, and nucleic acid-based drugs or vaccines related to thesite of administration and the target site. Many of the approachesdescribed are reported in formulations in current clinical trialsas well as in marketed products. Contents include: challenges in delivery of biopharmaceuticals novel formulation approaches for peptide and proteininjectables non-viral chemical vectors and viral technology for delivery ofnucleic acid based drugs immune response, adjuvants and delivery systems forvaccines several examples of delivery systems for differentbiopharmaceuticals a critical assessment of delivery technologies forbiopharmaceuticals Delivery Technologies for Biopharmaceuticals is anessential single-volume introduction to the technologies used byresearchers to ensure efficient delivery of this exciting new classof drugs. It will be of value to researchers and students workingin drug delivery, formulation, biopharmaceuticals, medicinalchemistry, and new materials development.

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Relevant, up-to-date publications will be made available via the online learning platform. 

Up to date links will be made available via the online learning platform. 

Relevant, up-to-date resources will be made available via the online learning platform.