[...]... 97 98 10 1 10 2 10 2 10 4 10 5 10 7 10 9 11 0 11 0 11 1 11 1 11 2 11 2 11 6 11 6 11 7 11 8 12 2 12 3 12 4 12 7 12 8 12 9 13 3 13 4 14 0 14 2 14 3 14 4 14 5 14 7 15 0 15 3 15 5 15 8 15 9 15 9 16 0 16 1 16 3 16 4 16 6 16 7 16 8 16 8 x CONTENTS Amino acid analysis Peptide mapping N-terminal sequencing Analysis of secondary and tertiary structure Endotoxin and other pyrogenic contaminants Endotoxin, the molecule Pyrogen detection DNA Microbial and. .. Interferon biotechnology Production and medical uses of IFN-a Medical uses of IFN-b Medical applications of IFN-g Interferon toxicity Additional interferons Conclusion Further reading 18 9 19 4 19 5 19 6 19 7 19 8 19 8 19 8 19 9 19 9 202 203 207 207 210 213 214 216 218 219 219 Chapter 5 223 Cytokines: interleukins and tumour necrosis factor Interleukin-2 (IL-2) IL-2 production IL-2 and cancer treatment IL-2 and infectious... diseases Safety issues Inhibition of IL-2 activity 225 228 228 230 2 31 2 31 CONTENTS xi Interleukin -1 (IL -1 ) The biological activities of IL -1 IL -1 biotechnology Interleukin-3: biochemistry and biotechnology Interleukin-4 Interleukin-6 Interleukin -1 1 Interleukin-5 Interleukin -1 2 Tumour necrosis factors (TNFs) TNF biochemistry Biological activities of TNF-a Immunity and inflammation TNF receptors TNF: therapeutic... Zidovudine Dexamethasone C8H9NO2 15 1 .16 Analgesic C13H16ClNO C11H12N2S C8H7ClN2O2S C8H11N5O3 C10H13N5O4 C22H29FO5 237.74 204. 31 230.7 225.2 267.2 392.5 Misoprostol Cimetidine C22H38O5 C10H16N6 382.5 252.3 Anaesthetic Anthelmintic Anti-hypertensive Anti-viral agent Anti-viral agent Anti-inflammatory and immunosuppressive agent Anti-ulcer agent Anti-ulcer agent Table 1. 2 Some pharmaceuticals which were... reading 16 9 17 0 17 1 17 3 17 3 17 4 17 6 17 9 18 0 18 1 18 2 18 3 18 5 Chapter 4 18 9 The cytokines — the interferon family Cytokines Cytokine receptors Cytokines as biopharmaceuticals The interferons The biochemistry of interferon-a Interferon-b Interferon-g Interferon signal transduction The interferon receptors The JAK–STAT pathway The interferon JAK–STAT pathway The biological effects of interferons The eIF-2a... (rhGH) and pituitary dwarfism Idiopathic short stature and Turner’s syndrome Metabolic effects of hGH GH, lactation and ovulation The gonadotrophins Follicle stimulating hormone (FSH), luteinizing hormone (LH) and human chorionic gonadotrophin (hCG) Pregnant mare serum gonadotrophin (PMSG) The inhibins and activins 303 304 304 307 307 311 312 314 317 320 3 21 3 21 324 325 325 327 328 328 330 330 3 31 3 31 3 31. .. PHARMACEUTICALS, BIOLOGICS AND BIOPHARMACEUTICALS Table 1. 11 15 Major androgens/anabolic steroids used medically Hormone Description Use Danazol Synthetic androgen Suppresses gonadotrophin production Exhibits some weak androgenic activity Methyltestosterone Synthetic androgen, longer circulatory half-life than testosterone Oxymetholone Stanozolol Synthetic androgen Synthetic androgen Testosterone Main androgen produced... extraction from natural (non-engineered) biological sources (Tables 1. 3 and 1. 4) As used herein, biotechnology medicines’ or ‘products of pharmaceutical biotechnology are afforded a much broader definition Unlike the term ‘biopharmaceutical’, the term PHARMACEUTICALS, BIOLOGICS AND BIOPHARMACEUTICALS 3 Table 1. 3 A summary of the definition of the terms ‘biologic’, ‘biopharmaceutical’ and biotechnology medicine’... marketing of generic biopharmaceuticals in regions such as the EU and USA is, however, unlikely to occur in the near future, mainly due to regulatory issues To date (mid-2002) no gene therapy based product has thus far been approved for general medical use (Chapter 11 ) Although gene therapy trials were initiated as far back as 19 90, the PHARMACEUTICALS, BIOLOGICS AND BIOPHARMACEUTICALS 11 Table 1. 7 Approximate... Chronic disease and cancer chemotherapy Additional non-renal applications Tolerability Thrombopoietin Further reading 257 258 259 259 2 61 263 264 267 267 268 2 71 272 273 273 275 Chapter 7 277 Growth factors Growth factors and wound healing Insulin-like growth factors (IGFs) IGF biochemistry IGF receptors IGF-binding proteins Biological effects IGF and fetal development IGFs and growth Renal and reproductive . CONTENTS Interleukin -1 (IL -1 ) 232 The biological activities of IL -1 233 IL -1 biotechnology 234 Interleukin-3: biochemistry and biotechnology 235 Interleukin-4 236 Interleukin-6 238 Interleukin -1 1 240 Interleukin-5. (WFI) 10 5 Distribution system for WFI 10 7 Documentation 10 9 Specifications 11 0 Manufacturing formulae, processing and packaging instructions 11 0 Records 11 1 Generation of manufacturing records 11 1 Sources. interferon family 18 9 Cytokines 18 9 Cytokine receptors 19 4 Cytokines as biopharmaceuticals 19 5 The interferons 19 6 The biochemistry of interferon-a 19 7 Interferon-b 19 8 Interferon-g 19 8 Interferon