The rise of bio- and nano-technology in the last decades has led to the emergence of a new and unique type of medicine known as non-biological complex drugs (NBCDs). This book illustrates the challenges associated with NBCD development, as well as the complexity of assessing the effects of manufacturing changes on innovator and follow-on batches of NBCDs. It also touches upon proven marketing authorization requirements for biosimilars that could be effective in evaluating follow-on NBCDs, including a demonstration of control over the manufacturing process and a need for detailed physico-chemical characterization and (pre)clinical tests. This book is meant to be used for years to come as a standard reference work for the development of NBCDs. Moreover, this book aims to stimulate discussions and further our thinking to ensure that decisions regarding the approval of complex drugs are made with relevant scientific data on the table.

Proteins are still gaining importance in the pharmaceutical world, where they are used to improve our arsenal of therapeutic drugs and vaccines and as diagnostic tools. Proteins are different from "traditional" low-molecular-weight drugs. As a group, they exhibit a number of biopharmaceutical and formulation problems. These problems have drawn considerable interest from both industrial and aca demic environments, forcing pharmaceutical scientists to explore a domain previ ously examined only by peptide and protein chemists. Biopharmaceutical aspects of proteins, e.g., low oral bioavailability, have been extensively investigated. Although all possible conventional routes of ad ministration have been examined for proteins, no real, generally applicable alter native to parenteral administration in order to achieve systemic effects has yet been discovered. Several of these biopharmaceutical options have been discussed in Volume 4 of this series, Biological Barriers to Protein Delivery. Proteins are composed of many amino acids, several of which are notorious for their chemical instability. Rational design of formulations that optimize the native structure and/or bioactivity of a protein is therefore of great importance when long shelf life is required, as it is for pharmaceutical products. This issue has also been examined in two prior volumes of this series: Volume 2: Stability of Protein Pharmaceuticals (Part A) and Volume 5: Stability and Characterization of Protein and Peptide Drugs."

The rise of bio- and nano-technology in the last decades has led to the emergence of a new and unique type of medicine known as non-biological complex drugs (NBCDs). This book illustrates the challenges associated with NBCD development, as well as the complexity of assessing the effects of manufacturing changes on innovator and follow-on batches of NBCDs. It also touches upon proven marketing authorization requirements for biosimilars that could be effective in evaluating follow-on NBCDs, including a demonstration of control over the manufacturing process and a need for detailed physico-chemical characterization and (pre)clinical tests. This book is meant to be used for years to come as a standard reference work for the development of NBCDs. Moreover, this book aims to stimulate discussions and further our thinking to ensure that decisions regarding the approval of complex drugs are made with relevant scientific data on the table.

This introductory text explains both the basic science and the applications of biotechnology-derived pharmaceuticals, with special emphasis on their clinical use. It serves as a complete one-stop source for undergraduate/graduate pharmacists, pharmaceutical science students, and for those in the pharmaceutical industry. The Fourth Edition will completely update the previous edition, and will also include additional coverage on the newer approaches such as oligonucleotides, siRNA, gene therapy and nanotech.

Proteins are still gaining importance in the pharmaceutical world, where they are used to improve our arsenal of therapeutic drugs and vaccines and as diagnostic tools. Proteins are different from "traditional" low-molecular-weight drugs. As a group, they exhibit a number of biopharmaceutical and formulation problems. These problems have drawn considerable interest from both industrial and aca demic environments, forcing pharmaceutical scientists to explore a domain previ ously examined only by peptide and protein chemists. Biopharmaceutical aspects of proteins, e.g., low oral bioavailability, have been extensively investigated. Although all possible conventional routes of ad ministration have been examined for proteins, no real, generally applicable alter native to parenteral administration in order to achieve systemic effects has yet been discovered. Several of these biopharmaceutical options have been discussed in Volume 4 of this series, Biological Barriers to Protein Delivery. Proteins are composed of many amino acids, several of which are notorious for their chemical instability. Rational design of formulations that optimize the native structure and/or bioactivity of a protein is therefore of great importance when long shelf life is required, as it is for pharmaceutical products. This issue has also been examined in two prior volumes of this series: Volume 2: Stability of Protein Pharmaceuticals (Part A) and Volume 5: Stability and Characterization of Protein and Peptide Drugs.

This book contains a selection of the papers presented at the meeting "Between Clone and Clinic" which was organised in March 1990 in Amsterdam by the dutch Organisation for Applied Research, TNO, and the University of Utrecht. The scope of this meeting was the development of biotechnological pharmaceuticals mainly made by recombinant DNA technology or monoclonal antibody techniques. All aspects concerning the development of the products after host cells producing them are obtained where discussed. The meeting was attended by twohundred specialists from all over the globe, including phar macologists, toxicologists, registration experts, Quality Assurence managers, production en gineers and physicians. Biotechnological pharmaceuticals are in general large and complex protein molecules. Bringing these products to the market poses other problems than encountered with the classical chemical drugs. The source of biotechnological pharmaceuticals are living cells. The function of cells are depend ent on many factors and the stability of production may be a problem. Good Laboratory and Manufactory Practices with Quality Control (GLP and GMP) are of paramount importance and are discussed in a number of papers. The products of the new biotechnology are often highly specific and only active in the human species. Also the side effects can only be studied in the clinical setting. Even when the product is active in animals there is the problem of antigenicity. During treatment the animals will produce antibodies which neutralise the activity. So safety testing may prove difficult."

Completely revised text that reflects to emergent trends and cutting-edge advances in pharmaceutical biotechnology, this Third Edition provides a well-balanced framework for understanding every major aspect of pharmaceutical biotechnology, including drug development, production, dosage forms, administration, and therapeutic developments. New chapters cover evolving areas regarding biopharmaceuticals, including oligonucleotides, siRNA and various monoclonal antibodies, immunogenicity, gene therapy, and the regulatory issues factoring into the biopharmaceutical approval process

This introductory text explains both the basic science, production, quality, dosage forms, administration, economic and regulatory aspects and the clinical applications of biotechnology-derived pharmaceuticals. It serves as a complete one-stop source for undergraduate/graduate pharmacists and pharmaceutical science students. An additional important audience are pharmaceutical scientists in industry and academia, particularly those who have not received formal training in pharmaceutical biotechnology and are inexperienced in this field. The rapid growth and advances in the field made it necessary to revise this textbook in order to continue providing up-to-date information and introduce readers to cutting edge knowledge and technology of this field. This Sixth Edition completely updates the previous edition and includes additional coverage on new approaches such as oligonucleotides, siRNA, mRNA, gene therapy, cell therapies, monoclonal antibodies and vaccines. With more than 3-million-chapter downloads, the fifth edition of the textbook has achieved widespread distribution as a key educational resource for the field of pharmaceutical biotechnology. 

This introductory text explains both the basic science and the applications of biotechnology-derived pharmaceuticals, with special emphasis on their clinical use. It serves as a complete one-stop source for undergraduate/graduate pharmacists, pharmaceutical science students, and for those in the pharmaceutical industry The Fourth Edition will completely update the previous edition, and will also include additional coverage on the newer approaches such as oligonucleotides, siRNA, gene therapy and nanotech.

Completely revised text that reflects to emergent trends and cutting-edge advances in pharmaceutical biotechnology, this Third Edition provides a well-balanced framework for understanding every major aspect of pharmaceutical biotechnology, including drug development, production, dosage forms, administration, and therapeutic developments. New chapters cover evolving areas regarding biopharmaceuticals, including oligonucleotides, siRNA and various monoclonal antibodies, immunogenicity, gene therapy, and the regulatory issues factoring into the biopharmaceutical approval process