分析部門

治療用蛋白質的免疫原性 5月3日∼4日

免疫原性在對安全性和效能的影響上，現在仍為生物製劑業界的一大隱憂。本學會聚焦在促使免疫原性的因素、預測工具的開發、克服此問題的方法等，並也介紹前臨床評價以及臨床評價的策略、風險評價、法規面的問題和方針等相關專家的建議。

第1天 | 第2天

5月3日, 星期四

12:00 pm Registration

Predictive Methods For Immunogenicity

1:30 Chairperson's Opening Remarks

1:40 Beyond in silico: Advancing Pre-Clinical Immunogenicity Testing

Jack Ragheb, M.D., Ph.D., Principal Investigator, Immunology, Therapeutic proteins, CDER/FDA - Biography

"Humanized" mice that fully recapitulate the human hematopoietic system may permit direct in vivo assessment of human immunogenicity to a therapeutic protein. This session will describe the nature, limitations, utility, and predictive value of in vitro and in vivo model systems. Case studies will illustrate how pre-clinical data and a risk-based assessment may help inform the probability of immunogenicity in humans.

2:10 Amgen's Perspective on Immunogenicity Prediction Tools and Efforts

Theresa J. Goletz, Ph.D., Senior Personalized Healthcare Leader, Clinical Immunology, Amgen, Inc. - Biography

Sponsored by
2:40 Sponsored Presentation Speaker to be Announced

2:55 Sponsored Presentation (Opportunity Available)

3:10 Refreshment Break in the Exhibit Hall with Poster Viewing

4:00-5:00 Problem Solving Breakout Discussions

第1天 | 第2天