| • |
Chamberlain P. Pre-clinical strategies and safety issues in developing therapeutic monoclonal antibodies. N Biotechnol. 2011.
|
| • |
Büttel IC, Chamberlain P, Schellekens H et al. Taking immunogenicity assessment of therapeutic proteins to the next level. Biologicals. 2011;39:100-9.
|
| • |
Carilho R, et al, Kromminga A, Costa J Erythropoietin and amyotrophic lateral sclerosis: Plasma level determination. Amyotroph Lateral Scler. 2011.
|
| • |
Wadhwa M, Thorpe R. Unwanted immunogenicity: lessons learned and future challenges. Bioanalysis. 2010;2:1073-84.
|
| • |
Kromminga A. Immune reactions induced by therapeutic proteins. In “From Pathogenesis to Therapy of Autoimmune Diseases” 2009;6:303-312.
|
| • |
Schmidt E, Hennig K, Mengede D, Zillikens D, Kromminga A. Immunogenicity of rituximab in patients with severe pemphigus. Clin Immunol. 2009;132:334-41.
|
| • |
Sauerborn M, Schellekens H. B-1 cells and naturally occurring antibodies: influencing the immunogenicity of recombinant human therapeutic proteins? Curr Opin Biotechnol. 2009;20:715-21.
|
| • |
Jahn EM, Schneider CK. How to systematically evaluate immunogenicity of therapeutic proteins - regulatory considerations. N Biotechnol. 2009;25:280-6.
|
| • |
Schellekens H
Biosimilar therapeutics-what do we need to consider? NDT Plus. 2009;2(Suppl 1):i27-i36.
|
| • |
Ponce R et al.
Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies. Regul Toxicol Pharmacol. 2009;54:164-82.
|
| • |
Pavlovic M, Girardin E, Kapetanovic L, Ho K, Trouvin JH.
Similar biological medicinal products containing recombinant human
growth hormone: European regulation. Horm Res. 2008;69:14-21.
|
| • |
Shankar G et al. Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. J Pharm Biomed Anal. 2008;48:1267-81. |
| • |
Koren E et al. Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products. J
Immunol Methods. 2008;333:1-9. |
| • |
Schellekens H. The first biosimilar epoetin: but how similar is it? Clin J Am Soc Nephrol. 2008;3:174-8.
|
| • | Gilli F, van Beers M, Marnetto F, Jiskoot W, Bertolotto A, Schellekens H.
Development of a bioassay for quantification of neutralising antibodies against human interferon-beta in mouse sera. J Immunol Methods. 2008
Apr 28. |
| • | Kirkov V, Dimitrova V, Siebert-Weigel M, Pflugmann MW, Koytchev R, Richter W, Bronn A, Arsova S,
Kromminga A. Evaluation of the Pharmakinetics of two recombinant human erythropoietin preparations: Epoetin Zeta and Epoetin Alfa. Drug
Research 2008; 58:215-219. |
| • | Kirkov V, Dimitrova V, Siebert-Weigel M, Pflugmann MW, Koytchev R, Richter W,
Bronn A, Arsova S, Kromminga A. Evaluation of the Pharmakinetics of two recombinant human erythropoietin preparations: Epoetin Zeta and Epoetin Alfa. Drug
Research 2008; 58:220-224.
|
| • | Scheidemann F, Löser M, Niedermeier A, Kromminga A, Therrien JP, Vogel J, Pfützner W.
The skin as a biofactory for systemic secretion of erythropoietin:
potential of genetically modified keratinocytes and fibroblasts. Exp
Dermatol. 2008;17:481-8.
|
| • | Jaber A, Baker M.
Assessment of the immunogenicity of different interferon beta-1a
formulations using ex vivo T-cell assays. J Pharm Biomed Anal.
2007;43:1256-61.
|
| • | Gupta S et al.
Recommendations for the design, optimization, and qualification of
cell-based assays used for the detection of neutralizing antibody
responses elicited to biological therapeutics. J Immunol Methods.
2007;321:1-18. |
| • | Van Walle I, Gansemans Y, Parren PW, Stas P, Lasters I. Immunogenicity screening in protein drug development. Expert Opin Biol Ther. 2007;7:405-18.
|
| • | Kromminga A, Deray G. Immunogenicity of rhEPO in "Immunogenicity of Biopharmaceuticals (ed. v.d.Weert/Möller). Springer, 2008; 113-126.
|
| • | Bendtzen K, Kromminga A. Immunogenicity of Interferon-beta in "Immunogenicity of Biopharmaceuticals (ed. v.d.Weert/Möller). Springer, 2008; 127-136.
|
| • |
Gupta S et al. Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics. J Immunol Methods. 2007;321:1-18.
|
| • | Jaber A, Schellekens H, Antonelli M. et al. The Rebif new formulation story: it's not trials and error. Drugs R D. 2007; 8:335-48.
|
| • | Bodó E, Kromminga A, Jelkmann W, Paus R. Human hair follicles are an extrarenal source and a nonhematopoietic target of erythropoietin.
FASEB J. 2007; 21:3346-54.
|
| • | Kessler M, Goldsmith D, Schellekens H. Immunogenicity of biopharmaceuticals. Nephrol Dial Transplant. 2006; 21 Suppl 5:v9-12.
|
| • | Schellekens H. 2007. Lesson learned from Eprex-associated pure red cell aplasia. Kidney Blood Press Res. 2007; 30 Suppl
1:9-12
|
| • | Schellekens H, Jiskoot W. Eprex-associated pure red cell aplasia
and leachates. Nat Biotechnol. 2006; 24:613-4.
|
| • | Kromminga A, Schellekens H. Antibodies against erythropoietin and other protein-based therapeutics: an overview. Ann N Y Acad Sci. 2005 1050:257-65.
|
| • | Tacey R, Kromminga A, Daha M, Casadevall N, Kelley M.
The
detection of anti-erythropoietin antibodies in human serum and plasma.
Part I. Validation of the protocol for a radioimmunoprecipitation
assay. J Immunol Methods. 2003; 283:317- 29.
|
