Unwanted Immunogenicity: Implications for Follow-on Biologicals
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Key Words Antibodies; Neutralizing; Assays: Prediction; Strategy
Correspondence Address D,: Meenu Wadhwa. Division of Immunology and Endocrinology, NIBSC. Blanche Lane, South Mimms, Potters Bar. Hertfordshire, EN6 3QG, UK (e-mail: mwadhwa @nibsc.ac.uk) . Presented at the Public Workshop FDA/DIA: “Scientific Considerations Related to Developing Follow-On Protein Pharmaceuticals.” February 14-16, 2005, Washington. DC. The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program is designated for a maximum of I contact hour or . I continuing education units (CEUs). 286-000-07-401 -H04. lfyou would like lo receive a statement ofcredit. you must review the article. answer the questions to the posttest on fhe Post-test and Evaluation Form and submit it lo the DIA. Participants must receive a passing score of 80% or better on the post-test in order to receive a statement ofcredit. Statements ofcredit will be mailed within one month of receipt ofthe Post-test and Evaluation Form. There is no fee to receiveyour statement of credit. Release Date: january 2007 Expiration Date: january 31,2008 Estimated time to complete the activity: I hour Robin Thorpe. PhD, FRCPath: no relationships to disclose Meenu Wadhwa, PhD: no relationships to disclose
Unwanted Immunogenicity: Implications for Follow-on Biologicals The unexpected and unpredictable development of unwanted immunogenicity is a significant issue affecting therapeutic proteins, including follow-on biologicals. The development of antibodies against the therapeutic biological can cause allergic or anaphylactic reactions, reduction in efficacy, and, in some cases, severe adverse effects. The risk of inducing immune responses is largely dependent on the recipient as well as a number of product-related factors (eg, production process, formulation, and number of
doses administered during the course of treatment). Consideration should be given to the evaluation of unwanted immunogenicity of fdlow-on bidogicals from preclinical development, through clinical trials, and into the postregistration period to minimize the risks associated with immunogenicity in recipients of therapeutic products. Properfy planned immunogenicity studies during phase IAI clinical trials using a range of carefilly validated procedures are needed to assess unwanted immunogenicity of therapeuticproducts.
Learning Objectives Upon completion of this article, participants should be able to Minimize risks by evaluatingunwanted immunogenicity of fdlow-on bidogicalsfrom preclinicd development through clinical trials and into the postregistrationperiod Design appropriate immunogenicity studies to assess unwanted immunogenicity of therapeutic products
Target Audience This article is designedfor clinicians, manufacturers of biotech products, and regulators.
I N T R O D U CTI 0 N The unprecedented success of therapeutic biological products used for treatment of a wide variety of chronic and sometimes life-threateni
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