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biopharmaceuticals biochemistry and biotecnology - Walsh G.

Walsh G. biopharmaceuticals biochemistry and biotecnology - John Wiley & Sons, 2003. - 572 p.
ISBN 0-470-84327-6
Download (direct link): biochemistryandbiotechnology2003.pdf
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Appendix 1
Biopharmaceuticals thus far approved in the USA or European Union
Notes: (a) Several products have been approved for multiple indications. Only the first indication for which each was approved is listed. (b) ‘Vet’ listing in therapeutic indication column indicates an animal application. All other products are used in human medicine.
Abbreviations: r = recombinant, rh = recombinant human, CHO = Chinese hamster ovary, BHK = baby hamster kidney, Mab = monoclonal antibody, tPA = tissue plasminogen activator, hGH = human growth hormone, FSH = follicle stimulating hormone, TSH = thyroid stimulating hormone, EPO = erythropoietin, GM-CSF = granulocyte-macrophage colony stimulating factor, IFN=interferon, IL = interleukin, HBsAg = hepatitis B surface antigen, PDGF = platelet-derived growth factor, TNFR = tumour necrosis factor receptor, E. coli = Escherichia coli, S. cerevisiae = Saccharomyces cerevisiae.
Product Company Therapeutic indication Date approved
Recombinant blood factors
Bioclate (rhFactor VIII produced Centeon Haemophilia A 1993 (USA)
in CHO cells)
Benefix (rhFactor IX produced Genetics Institute Haemophilia B 1997 (USA, EU)
in CHO cells)
Kogenate (rhFactor VIII produced Bayer Haemophilia A 1993 (USA), 2000
in BHK cells. Also sold as (EU)
Helixate by Centeon via a license
agreement)
Helixate NexGen (octocog-a; Bayer Haemophilia A 2000 (EU)
rhFactor VIII produced in
BHK cells)
NovoSeven (rhFactor VIIa Novo Nordisk Some forms of 1995 (EU), 1999
produced in BHK cells) haemophilia (USA)
(Continued)
Biopharmaceuticals: Biochemistry and Biotechnology, Second Edition by Gary Walsh
John Wiley & Sons Ltd: ISBN 0 470 84326 8 (ppc), ISBN 0 470 84327 6 (pbk)
500 BIOPHARMACEUTICALS
Product
Company
Therapeutic-indication Date approved
Recombinate (rhFactor VIII produced in an animal cell line) ReFacto (Moroctocog-a, i.e. B-domain-deleted rhFactor VIII produced in CHO cells)
Baxter Healthcare/ Haemophilia A Genetics Institute Genetics Institute Haemophilia A
Recombinant tissue plasminogen activator-based products
Activase (Alteplase, rh-tPA Genentech
produced in CHO cells)
Ecokinase (Reteplase, rtPA; differs Galenus from human tPA in that three Mannheim
of its five domains have been deleted. Produced in E. coli)
Retavase (Reteplase, rtPA; see Boehringer-
Ecokinase) Mannheim/
Centocor
Rapilysin (Reteplase, rtPA; Boehringer-
see Ecokinase) Mannheim
Tenecteplase (also marketed as Boehringer-
Metalyse) (TNK-tPA, modified Ingelheim
rtPA produced in CHO cells)
TNKase (Tenecteplase; modified Genentech
rtPA produced in CHO cells; see Tenecteplase)
Recombinant hormones
Humulin (rhInsulin produced Eli Lilly
in E. coli)
Novolin (rhInsulin) Novo Nordisk
Humalog (Insulin Lispro, an Eli Lilly
insulin analogue produced in E. coli)
Insuman (rhInsulin produced Hoechst AG
in E. coli)
Liprolog (Bio Lysprol, a short- Eli Lilly
acting insulin analogue produced in E. coli)
NovoRapid (Insulin Aspart, short- Novo Nordisk
acting rhInsulin analogue)
Novomix 30 (contains Insulin Novo Nordisk
Aspart, short acting rhInsulin analogue — see NovoRapid — as one ingredient)
Novolog (Insulin Aspart, short- Novo Nordisk
acting rhInsulin analogue produced in S. cerevisiae. See also Novorapid)
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