Managing Immunogenicity Risk in Biopharmaceuticals - Webinar By ComplianceOnline (Biotech Training)
Venue: Online Event
|Event Date/Time: Mar 08, 2012||End Date/Time: Mar 08, 2012|
This presentation begins with an overview of the biological self versus non-self mechanism resulting in the anti-drug response of biopharmaceuticals. The next section describes how to differentiate the risk associated with internal attributes of the drug from the risk derived from external factors. That guideline in conjunction with the latest industry recommendations and regulatory guidelines provides a logical approach to the risk strategy.
The second-half of the presentation demonstrates how to use pre-clinical results to further characterize (but not predict) the immunogenicity response and utilize this information to be ready for adverse effects during clinical trials. The presentation finishes with recommendations on a sampling strategy and a representative clinical case study describing the importance of immunogenicity testing not only during clinical trials but also after the drug is commercialized.