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By Heather Myler

Heather MylerImmunogenicity refers to the elicitation of an immune response following administration of a foreign antigen, in most cases, a biotherapeutic. While there are some product design, quality, and patient characterization factors that may help scientists and clinicians predict the probability and clinical consequences of an unwanted immune response, clinical trials are really the only reliable sources for the affirmation of such a hypothesis.

Health authorities have provided valuable guidances on how to incorporate immunogenicity testing into the drug development process. These guidances have been written by knowledgeable agents, many of whom are immersed within the AAPS immunogenicity community, frequently collaborating on manuscripts, participating in symposia, and consulting for the BIOTEC section focus groups, especially LBABFG, TPIFG and PABC. This teamwork between health authorities and industry professionals has truly advanced the science providing a collegial environment for sharing experiences and, as a result, continues to advance patient outcome.

The AAPS Immunogenicity 101 eCourse is just another prime example of how thought industry leaders and health authorities are coming together to share lessons learned and provide insights on this sometimes mysterious and frequently unpredictable drug development component. Whether you are new to immunogenicity or have been a faithful student for many decades, this course is guaranteed to provide new insights and may even reignite some dormant interests.

So this week, the AAPS Blog will highlight posts about the hottest trends surrounding this extensive and ever-growing field! Enjoy!

Heather Myler received her Ph.D. in biochemistry, cellular biology and bioengineering from Rice University. She has held positions of increasing responsibility supporting the bioanalysis of biotherapeutics at all stages of drug development at Pfizer, Amgen, Ambrx, and Merck; she currently serves as Principal Investigator in the Analytical and Bioanalytical Department at Bristol-Myers Squibb.