Strategies for preclinical immunogenicity assessment of protein therapeutics

IDrugs

Volumn 12, Issue 3, 2009, Pages 169-173

  Stas, P ^a   Lasters, I ^a  

^a Algonomics   (Belgium)

Author keywords

Biotherapeutic; Immunogenicity; Preclinical investigation; Therapeutic antibody

Indexed keywords

ANTIBODY; BETA INTERFERON; HLA ANTIGEN CLASS 2;

ANTIGEN PRESENTING CELL; CLINICAL ASSESSMENT; DRUG EFFICACY; DRUG PROTEIN BINDING; DRUG SCREENING; GENOMICS; HELPER CELL; HUMAN; IMMUNE SYSTEM; IMMUNOGENICITY; IMMUNOLOGICAL MEMORY; IN VITRO STUDY; IN VIVO STUDY; MASS SPECTROMETRY; NONHUMAN; REVIEW; RISK ASSESSMENT; T LYMPHOCYTE ACTIVATION; TRANSGENIC MOUSE;

ANIMALS; ANTIBODIES; ANTIBODY FORMATION; DRUG DESIGN; DRUG EVALUATION, PRECLINICAL; HUMANS; RECOMBINANT PROTEINS; RISK ASSESSMENT; T-LYMPHOCYTES;

EID: 62249171454     PISSN: 13697056     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (10)

1. EMEA: Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins. Press Release (2007): January 24.
2. Gupta S, Indelicato SR, Jethwa V, Kawabata T, Kelley M, Mire-Sluis AR, Richards SM, Rup B, Shores E, Swanson SJ, Wakshull E: 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(1-2):1-18.
3. Koren E, Smith HW, Shores E, Shankar G, Finco-Kent D, Rup B, Barrett YC, Devanarayan V, Gorovits B, Gupta S, Parish T et al: Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products. J Immunol Methods (2008) 333(1-2):1-9.
4. Mire-Sluis AR, Barrett YC, Devanarayan V, Koren E, Liu H, Maia M, Parish T, Scott G, Shankar G, Shores E, Swanson SJ et al: Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J Immunol Methods (2004) 289(1-2):1-16.
5. Rosenberg AS, Worobec A: A risk-based approach to immunogenicity concerns of therapeutic protein products - Part 1 - Considering consequences of the immune response to a protein. Biopharm Int (2004) 17:22-26.
6. Rosenberg AS, Worobec A: A risk-based approach to immunogenicity concerns of therapeutic protein products - Part 2 - Considering host-specific and product-specific factors impacting immunogenicity. Biopharm Int (2004) 17:34-42.
7. Rosenberg AS, Worobec A: A risk-based approach to immunogenicity concerns of therapeutic protein products - Part 3 - Effects of manufacturing changes in immunogenicity and the utility of animal immunogenicity studies. Biopharm Int (2005) 18:32-36.
8. Shankar G, Pendley C, Stein KE: A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs. Nat Biotechnol (2007) 25(5):555-561.
9. Shankar G, Devanarayan V, Amaravadi L, Barrett YC, Bowsher R, Finco-Kent D, Fiscella M, Gorovits B, Kirschner S, Moxness M, Parish T et al: Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. J Pharm Biomed Anal (2008) 48(5):1267-1281.
10. Van Walle I, Gansemans Y, Parren P, Stas Ph, Lasters L: Immunogenicity screening in protein drug development. Expert Opin Biol Ther (2007) 7(3):405-418.