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Biopharmaceuticals, an Industrial Perspective provides a unique and up-to-date insight into the biopharmaceutical industry. Largely written by industrial authors, its scope is multidisciplinary. Several chapters overview the production and medical applications of specific biopharmaceuticals. Other chapters detail additional relevant issues, including the stabilisation of biopharmaceutical products, EU biopharmaceutical regulatory affairs and biopharmaceutical patent law. A series of four chapters reviews important validation issues as applied to biopharmaceutical manufacturing. Additional issues considered include biopharmaceutical information technology as well as viral and non-viral gene therapy.
The book is of particular relevance to scientists and allied professionals already employed in the biopharmaceutical industry, or to those seeking employment within this industry. Its scope also renders it an ideal reference source for students undertaking advanced undergraduate or postgraduate courses in biotechnology, pharmaceutical science, biochemistry or medicine.
List of contents
Biopharmaceuticals, an overview.- Abciximab: The First Platelet Glycoprotein IIb/IIIa Receptor Antagonist.- Recombinant Coagulation Factor IX (BeneFix®).- Biopharmaceutical Drug Development: A Case History.- Follitropin beta (Puregon).- Insulin Lispro (Humalog).- Interferon beta-1b - the first long-term effective treatment of relapsing-remitting and secondary progressive multiple sclerosis (MS).- Reteplase, a recombinant plasminogen activator.- Stabilisation of biopharmaceutical products and finished product formulations.- Patent Law for Biopharmaceuticals.- The development of new medicines: an overview.- The EMEA and regulatory control of (bio)pharmaceuticals within the European Union.- Biopharmaceutical Validation: an overview.- Validation of Biopharmaceutical Chromatography Systems.- Validation of Water for Injections (WFI) for Biopharmaceutical Manufacture.- Information retrieval and the biopharmaceutical industry: an introductory overview.- Information technology and the internet as a resource of biopharmaceutical information.- Marketing Issues for the (Bio)pharmaceutical sector.- Viral mediated gene therapy.- Pharmaceutical gene medicines for non-viral gene therapy.
