Ebook: Biopharmaceuticals, an Industrial Perspective

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.

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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.

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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.
Content:
Front Matter....Pages N3-x
Biopharmaceuticals, an overview....Pages 1-34
Abciximab: The First Platelet Glycoprotein IIb/IIIa Receptor Antagonist....Pages 35-71
Recombinant Coagulation Factor IX (BeneFIX®)....Pages 73-108
Biopharmaceutical Drug Development: A Case History....Pages 109-123
Follitropin beta (Puregon)....Pages 125-148
Insulin Lispro (Humalog)....Pages 149-171
Interferon beta-1b — the first long-term effective treatment of relapsing-remitting and secondary progressive multiple sclerosis (MS)....Pages 173-184
Reteplase, a recombinant plasminogen activator....Pages 185-216
Stabilisation of biopharmaceutical products and finished product formulations....Pages 217-248
Patent Law for Biopharmaceuticals....Pages 249-267
The development of new medicines: an overview....Pages 269-287
The EMEA and regulatory control of (bio)pharmaceuticals within the European Union....Pages 289-310
Biopharmaceutical Validation: an overview....Pages 311-335
Validation of Biopharmaceutical Chromatography Systems....Pages 337-362
Validation of Water for Injections (WFI) for Biopharmaceutical Manufacture....Pages 363-387
Information retrieval and the biopharmaceutical industry: an introductory overview....Pages 389-404
Information technology and the internet as a resource of biopharmaceutical information....Pages 405-419
Marketing Issues for the (Bio)pharmaceutical sector....Pages 421-441
Viral mediated gene therapy....Pages 443-469
Pharmaceutical gene medicines for non-viral gene therapy....Pages 471-504
Back Matter....Pages 505-514

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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.
Content:
Front Matter....Pages N3-x
Biopharmaceuticals, an overview....Pages 1-34
Abciximab: The First Platelet Glycoprotein IIb/IIIa Receptor Antagonist....Pages 35-71
Recombinant Coagulation Factor IX (BeneFIX®)....Pages 73-108
Biopharmaceutical Drug Development: A Case History....Pages 109-123
Follitropin beta (Puregon)....Pages 125-148
Insulin Lispro (Humalog)....Pages 149-171
Interferon beta-1b — the first long-term effective treatment of relapsing-remitting and secondary progressive multiple sclerosis (MS)....Pages 173-184
Reteplase, a recombinant plasminogen activator....Pages 185-216
Stabilisation of biopharmaceutical products and finished product formulations....Pages 217-248
Patent Law for Biopharmaceuticals....Pages 249-267
The development of new medicines: an overview....Pages 269-287
The EMEA and regulatory control of (bio)pharmaceuticals within the European Union....Pages 289-310
Biopharmaceutical Validation: an overview....Pages 311-335
Validation of Biopharmaceutical Chromatography Systems....Pages 337-362
Validation of Water for Injections (WFI) for Biopharmaceutical Manufacture....Pages 363-387
Information retrieval and the biopharmaceutical industry: an introductory overview....Pages 389-404
Information technology and the internet as a resource of biopharmaceutical information....Pages 405-419
Marketing Issues for the (Bio)pharmaceutical sector....Pages 421-441
Viral mediated gene therapy....Pages 443-469
Pharmaceutical gene medicines for non-viral gene therapy....Pages 471-504
Back Matter....Pages 505-514
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