SOURCE: Xtalks

Xtalks Webinars

November 06, 2015 07:00 ET

Strategies for Effective Neutralizing Cell Based Assays in Early Immunogenicity Risk Assessment, New Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - November 06, 2015) - Join Paul W. Rhyne, Ph.D., Scientific Director for Q2 Solutions, a Quintiles Quest Joint as he discusses the challenges and the importance of NAb assays and a well thought out immunogenicity strategy in drug development to assess and mitigate risk. The live broadcast takes place on Wednesday, November 18, 2015 at 11am EST (4pm GMT).

Traditionally, small molecules have dominated the pharmaceutical market. These chemical entities have helped to improve dramatically the quality of life by treating a broad range of diseases and illnesses. The past decade has witnessed a remarkable increase in large molecule, antibody-based therapies. It is forecasted that by 2016 the dominance of small molecules will have been replaced by more complex, protein drugs or biologics. Biologics are a class of drugs of growing importance because they offer unique modes of action with far fewer side effects but they are expensive to develop and to bring to the market.

One potential obstacle impacting drug development is the occurrence of anti-drug antibodies generated by the immune response of the patients receiving such drug. These anti-drug antibodies that bind to the drug have the potential to neutralize its activity in treated patients. Neutralizing antibodies (NAbs) can impact the efficacy and safety of the drug depending on patient-related and product-related factors. In addition, there are instances where NAbs have caused infusion reactions and deficiency syndromes. The FDA provides guidance pertaining to immunogenicity risk management for biologics including risk assessment and mitigation, and NAb detection and assay selection.

NAb assays are secondary characterization assays designed to determine whether anti-drug antibodies specifically neutralize drug activity. Two types of assays have been used to measure NAbs: cell-based biologic assays and non-cell based ligand binding assays. The FDA recommends that cell-based biologic assays be used when possible since these are considered to be more reflective of the in vivo situation. The NAb assay should also be reflective of the drugs mechanism of action. Thus, NAb detection is important in interpreting the therapeutics' efficacy and safety in vivo.

To learn more about this event visit: Strategies for Effective Neutralizing Cell Based Assays in Early Immunogenicity Risk Assessment

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