Handbook of biogeneric theraupetic proteins : regulatory, manufacturing, testing, and patent issues /: regulatory, manufacturing, testing, and patent issues. (©2005)

• Record Type: Book
• Further Information: Note: Safaraz K. Niazi.
• Other Names: Niazi, Sarfaraz, 1949-
• Contents: Front cover; Foreword; Preface; About the Author; Author's Comments; List of Figures; List of Tables; Contents; 1; The Frontiers of Biotechnology; Introduction; Biotechnology Frontiers; Enhanced Quantity and Quality of Human Life; Eugenics and Cloning; Technology Trends: Genomics; Genetic Profiling and DNA Analysis; Proteomics; Cloning; Genetically Modified Cells; Broader Issues and Implications; Therapies and Drug Development; Technology; Surgical and Diagnostic Biotechnology; Broader Issues and Implications; Recombinant Production Systems; Drug Delivery Systems; Encapsulation Technologies. Transdermal ApplicationsChemical Modification; Pulmonary Delivery; A Time Line of Biotechnology Development; 8000 B.C.; 4000-2000 B.C.; 1750 B.C.; 500 B.C.; 100 A.D.; 1322; 1590; 1665; 1675; 1761; 1796; 1830; 1833; 1835-1855; 1857; 1859; 1865; 1870-1890; 1877; 1878; 1879; 1900; 1902; 1906; 1911; 1914; 1915; 1919; 1920; 1928; 1930; 1933; 1938; 1940; 1941; 1942; 1943; 1944; 1946; 1949; 1950; 1951; 1953; 1955; 1956; 1958; 1959; Also in the 1950s; 1960; 1961; 1963; 1964; 1965; 1966; 1967; 1969; 1970; 1971; 1972; 1973; 1974; 1975; 1976; 1977; 1978; 1979; Also in the 1970s; 1980; 1981; 1982; 1983. 19841985; 1986; 1987; 1988; 1989; Also in the 1980s; 1990; 1991; 1992; 1993; 1994; 1995; 1996; 1997; 1998; Also in the 1990s; 2000; 2001; 2002; 2003; 2004; 2; Marketing Opportunities; Introduction; Sales, Patents, and Approvals; Biogeneric Products Pathway; Case Law; Pharmacopoeia Efforts; Legislative Action; Technology Advances; Scientific Rationale; 3; Manufacturing Overview; Introduction; Manufacturing Process; Cell Culture Expression Systems; Bacteria; Yeast; Insect Cells; Mammalian Cells; Transgenic Animals; Cell Lines and Characterization; Media; Culture Growth. Extraction, Isolation, and PurificationCapture; Purification; Polishing; Impurity Removal; Formulation; Validation; Process Overview; Process Maturity; Scale Up; Technology Transfer; Process Optimization and Cost Reduction; Process Materials; Environment Control; NIH Guidelines for Handling DNA Material; Biosafety Levels; Good Manufacturing Controls of Active Pharmaceutical Ingredients; Manufacturing Systems and Layout; Cleaning Procedures; Processing and Filling; Laboratory Testing; Laboratory Controls; Documentation; Technical Package; Outsourcing in Biotech Manufacturing; Issues to discuss. Contract Manufacturing Organizations (CMOs)Microbial CMOs; Insect Cell CMOs; Mammalian CMOs; Transgenic Animal CMOs; Transgenic Plant CMOs; Contract Service Organizations (CSOs); Other Useful Links; 4; Genetically Modified Cells; Introduction; Cell Line Characterization; Cell Line Selection; Cell Line Construction; Designing GMCs; Gene Construct; Vector; Host Systems; Expression System in E. coli; Configuration of Efficient Expression Vectors; Protein Production; Strategies for Production; Production by Secretion; Secretion into the Culture Medium; Secretion to the Periplasmic Space.
• Publisher Details: Boca Raton : Taylor & Francis
• Publication Date: 2005
• Copyright Date: 2005
• Extent: 1 online resource (554 pages), illustrations
• Subjects: 338.4/76153; Protein drugs; Generic drugs; Recombinant proteins; Pharmaceutical biotechnology industry; Recombinant proteins -- Therapeutic use; Technology, Pharmaceutical; Drug industry; Médicaments protéiques; Médicaments génériques; Protéines recombinantes; Biotechnologie pharmaceutique -- Industrie; BUSINESS & ECONOMICS -- Industries -- Service; Generic drugs; Pharmaceutical biotechnology industry; Protein drugs; Recombinant proteins; Recombinant Proteins -- therapeutic use; Drug Industry; Technology, Pharmaceutical; Electronic books; Fulltext; Handbook; Internet Resource; Illustration; Electronic books
• Languages: English
• ISBNs: 1420037935; 9781420037937; 0849329914; 9780849329913
• Notes: Note: Includes bibliographical references and index.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.