New FDA draft guidance on immunogenicity

AAPS Journal

Volumn 16, Issue 3, 2014, Pages 499-503

  Parenky, Ashwin ^f   Myler, Heather ^a   Amaravadi, Lakshmi ^b   Bechtold Peters, Karoline ^c   Rosenberg, Amy ^d   Kirshner, Susan ^d   Quarmby, Valerie ^e  

^a BRISTOL MYERS SQUIBB   (United States)

^b BIOGEN   (United States)

^c Clinical Manufacturing Process Science and Business Excellence Pharmaceutical Development and Supplies F Hoffmann La Roche   (Switzerland)

^d Center for Drug Evaluation and Research   (United States)

^e GENENTECH INC   (United States)

^f MERCER UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BETA INTERFERON; EXCIPIENT; TUMOR NECROSIS FACTOR ALPHA INHIBITOR; PROTEIN;

CONFERENCE PAPER; DEAMINATION; DEGRADATION; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; GLYCOSYLATION; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; ISOMERIZATION; NONHUMAN; PATIENT SAFETY; PREDICTION; RISK ASSESSMENT; ANIMAL; IMMUNOLOGY; PRACTICE GUIDELINE; UNITED STATES;

ANIMALS; GUIDELINES AS TOPIC; HUMANS; PROTEINS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84900344672     PISSN: None     EISSN: 15507416     Source Type: Journal    
DOI: 10.1208/s12248-014-9587-6     Document Type: Conference Paper

References (6)

1. Guidance for Industry Immunogenicity Assessment for Therapeutic Protein Products [Internet]. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM338856.pdf. Accessed Feb 2013.
2. Stirling A, Gee D. Science, precaution, and practice. Public Health Rep Wash DC 1974. 2002 117(6):521-33.
3. Xue L, Rup B. Evaluation of pre-existing antibody presence as a risk factor for posttreatment anti-drug antibody induction: analysis of human clinical study data for multiple biotherapeutics. AAPS J. 2013;15(3):893-6.
4. Hausmann OV, Seitz M, Villiger PM, Pichler WJ. The complex clinical picture of side effects to biologicals. Med Clin North Am. 2010;94(4):791-804. xi-ii.
5. Seidl A, Hainzl O, Richter M, Fischer R, Böhm S, Deutel B, et al. Tungsten-induced denaturation and aggregation of epoetin alfa during primary packaging as a cause of immunogenicity. Pharm Res. 2012;29(6):1454-67.
6. Meyer BK, Ni A, Hu B, Shi L. Antimicrobial preservative use in parenteral products: past and present. J Pharm Sci. 2007;96(12):3155-67.