Discovery and development of biopharmaceuticals: current issues

Current Opinion in Biotechnology

Volumn 20, Issue 6, 2009, Pages 668-672

  Strohl, William R ^a   Knight, David M ^a  

^a CENTOCOR INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; AMYLOID BETA PROTEIN ANTIBODY; BEVACIZUMAB; CD20 ANTIBODY; CD20 ANTIGEN; CD3 ANTIBODY; CERTOLIZUMAB PEGOL; DIPHTHERIA TOXIN; ETANERCEPT; GRANULOCYTE COLONY STIMULATING FACTOR; GROWTH HORMONE; HUMAN INSULIN; INFLIXIMAB; INSULIN; INTERLEUKIN 13; INTERLEUKIN 13 ANTIBODY; INTERLEUKIN 4; INTERLEUKIN 6; INTERLEUKIN 6 ANTIBODY; RECOMBINANT DNA; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RITUXIMAB; SIMPONI; SOMATOMEDIN C RECEPTOR; TRASTUZUMAB; TUMOR NECROSIS FACTOR ALPHA; TUMOR NECROSIS FACTOR ALPHA ANTIBODY; UNCLASSIFIED DRUG; UNINDEXED DRUG; VASCULOTROPIN ANTIBODY; VASCULOTROPIN RECEPTOR;

BIOLOGICAL THERAPY; CLINICAL TRIAL; DIPHTHERIA; DRUG RESEARCH; DRUG SAFETY; DRUG TARGETING; EDITORIAL; EYE DISEASE; FINANCIAL MANAGEMENT; GROWTH HORMONE DEFICIENCY; HUMAN; INFLAMMATION; INSULIN DEPENDENT DIABETES MELLITUS; MALIGNANT NEOPLASTIC DISEASE; METABOLIC DISORDER; NEUROLOGIC DISEASE; NEUTROPENIA; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROTEIN ENGINEERING; RECOMBINANT DNA TECHNOLOGY;

ANIMALS; ANTIBODIES; BIOPHARMACEUTICS; BIOTECHNOLOGY; DNA; DRUG DESIGN; HUMANS; PHARMACEUTICAL PREPARATIONS; PROTEINS; TECHNOLOGY, PHARMACEUTICAL;

EID: 70449723296     PISSN: 09581669     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.copbio.2009.10.012     Document Type: Editorial

References (26)

1. Strohl WR: Therapeutic monoclonal antibodies-past, present, and future. In Therapeutic monoclonal antibodies: from bench to clinic. Edited by An Z. John Wiley & Sons, New York, 2009: 4-50. A comprehensive look at the field of monoclonal antibodies along with the challenges and issues that face discovery and development of monoclonal antibodies and Fc-fusion proteins over the next decade.
2. Durocher Y, Butler M: Expression systems for therapeutic glycoprotein production. This issue, 2009.
3. Leader B., Baca Q.J., and Golan D.E. Protein therapeutics: a summary and pharmacological classification. Nat Rev Drug Discov 7 (2008) 21-39. A comprehensive classification of therapeutic proteins that organizes them by form and function, and helps to bring order to the field.
4. La Merie Business Intelligence: Top 20 Biologics 2008. R&D Pipeline News (www.lamerie.com); March 9, 2009:1-25. Updated market information on therapeutic proteins.
5. Johnson-Ledger C., Power C.A., Shomade G., Shaw J.P., and El Proudfoot A. Protein therapeutics-lessons learned and a view of the future. Expert Opin Biol Ther 6 (2006) 1-7
6. Williams BR, Strohl WR: Follow-on protein products: what, where, when, how? In An, Zhiqiang. Therapeutic Antibodies, from Bench to Clinic. Edited by An Z. John Wiley & Sons, New York, 2009: pp. 759-773.
7. Osborne R. Brand biologics grab 12 years' exclusivity, for now. Nat Biotechnol 8 (2009) 677-678
8. Roger S.D., and Goldsmith D. Biosimilars: it's not as simple as cost alone. J Clin Pharm Ther 33 (2008) 459-464
9. Mellstedt H., Niederwieser D., and Ludwig H. The challenge of biosimilars. Ann Oncol 19 (2008) 411-419
10. Schellekens H. Biosimilar therapeutics-what do we need to consider?. NDT Plus 2 Suppl. 1 (2009) i27-i36
11. Cartron G., Dacheux L., Salles G., Solal-Celigny P., Bordos P., Colombat P., and Watier H. Therapeutic activity of humanized anti-CD20 monoclonal antibody and polymorphism in igG Fc receptor FcgammaRIIIa gene. Blood 99 (2002) 754-758
12. Weng W.K., and Levy R. Two immunoglobulin G fragment C receptor polymorphisms independently predict response to rituximab in patients with follicular lymphoma. J Clin Oncol 21 (2003) 3940-3947
13. Ghielmini M., Rufibach K., Salles G., Leoncini-Franscini L., Léger-Falandry C., Cogliatti S., Fey M., Martinelli G., Stahel R., Lohri A., et al. Single agent rituximab in patients with follicular or mantle cell lymphoma: clinical and biological factors that are predictive of response and event-free survival as well as the effect of rituximab on the immune system: a study of the Swiss Group for Clinical Cancer Research (SAKK). Ann Oncol 16 (2005) 1675-1682
14. Bello C., and Sotomayor E.M. Monoclonal antibodies for B cell lymphomas: rituximab and beyond. Hematol Am Soc Hematol Educ Program (2007) 233-242
15. Carter P.J. Potent antibody therapeutics by design. Nat Rev Immunol 6 (2006) 343-357
16. Presta L.G. Molecular engineering and design of therapeutic antibodies. Curr Opin Immunol 20 (2008) 460-470
17. Strohl WR: Optimization of Fc-mediated effector functions of monoclonal antibodies. This issue, 2009.
18. Stebbings R, Poole S, Thorpe R: Safety of biologics, lessons learnt from TGN1412. This issue, 2009.
19. Shire SJ: Formulation and manufacturability of biologics. This issue, 2009.
20. Li H, d'Anjou M: Pharmacological significance of glycosylation in therapeutic proteins. This issue, 2009.
21. Kola I. The state of innovation in drug development. Clin Pharmacol Ther 83 (2008) 227-230
22. Koren E., Smith H.W., Shores E., Shankar G., Finco-Kent D., Rup B., Barrett Y.C., Devanarayan V., Gorovits B., Gupta S., et al. Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products. J Immunol Methods 333 (2008) 1-9. The first of three cross-industry papers on immunogenicity of protein therpaeutics; this one focuses on the balance of risk versus value for methods used in determining anti-protein drug responses.
23. Shankar G., Devanarayan V., Amaravadi L., Smith H., Barrett Y.C., Bowsher R., Finco-Kent D., Fiscella M., Gorovits B., Kirschner S., et al. Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. J Pharm Biomed Anal 48 (2008) 1267-1281. The second of three cross-industry papers on immunogenicity of protein therapeutics; this one focuses on validation of the assays used to determine anti-protein drug responses.
24. Ponce R., Abad L., Amaravadi L., Gelzleichter T., Gore E., Green J., Gupta S., Herzyk D., Hurst C., Ivens I.A., et al. Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies. Regul Toxicol Pharmacol 54 (2009) 164-182. The third of three cross-industry papers on immunogenicity of protein therapeutics; this one focuses on the value and impact of non-clinical in vivo studies testing immune response toward therapeutic proteins.
25. Dasgupta S., Bayry J., André S., Dimitrov J.D., Kaveri S.V., and Lacroix-Desmazes S. Auditing protein therapeutics management by professional APCs: toward prevention of immune responses against therapeutic proteins. J Immunol 181 (2008) 1609-1615
26. Sauerborn M, Schellekens H: B-1 cells and naturally occurring antibodies: influencing the immunogenicity of recombinant human therapeutic proteins? This issue, 2009.