Literature review in support of adjuvanticity/ immunogenicity assessment of proteins

On The Agenda
From: Antonio C.
Added: 11.04.2021
Share this post:
BIO represents more than 1, biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment. In general, the Draft Guidance is very well written and provides a useful review of the numerous factors that can affect immunogenicity. BIO generally agrees with the risk-based approach presented in the Draft Guidance but recommends that FDA set a minimum level of required immunogenicity testing for all therapeutic protein products to provide clarity for potential Sponsors and to ensure safety and efficacy for patients.

Clinical Immunogenicity Risk Assessment Strategy for a Low Risk Monoclonal Antibody

Clinical Immunogenicity Risk Assessment Strategy for a Low Risk Monoclonal Antibody | SpringerLink

Immunogenicity is a significant concern for biologic drugs as it can affect both safety and efficacy. To date, the descriptions of product immunogenicity have varied not only due to different degrees of understanding of product immunogenicity at the time of licensing but also due to an evolving lexicon that has generated some confusion in the field. In recent years, there has been growing consensus regarding the data needed to assess product immunogenicity. Harmonization of the strategy for the elucidation of product immunogenicity by drug developers, as well as the use of defined common terminology, can benefit medical practitioners, health regulatory agencies, and ultimately the patients. Clearly, understanding the incidence, kinetics and magnitude of anti-drug antibody ADA , its neutralizing ability, cross-reactivity with endogenous molecules or other marketed biologic drugs, and related clinical impact may enhance clinical management of patients treated with biologic drugs.

Immunogenicity Assessment

Skip to search form Skip to main content You are currently offline. Some features of the site may not work correctly. DOI: Kosti and M. Triga and S.
The response in the assay to 10 monoclonal antibodies was found to be in agreement with the clinical immunogenicity, suggesting that the assay might be applied to immunogenicity risk assessment of antibody biotherapeutic attributes. However, the response in the assay is a measure of T-cell functional activity and the alignment with clinical immunogenicity depends on several other factors. The assay was sensitive to sequence variants and could differentiate single point mutations of the same biotherapeutic.

Most Viewed:

Write a comment

Click on the image to refresh the code if it is illegible
Nico E. 12.04.2021
The teachers are enraged, they send home assignments at the last moment.
Nguyen H. 14.04.2021
They went beyond and provided an excellent piece of article.
Wendy J. 15.04.2021
Every professional needs to complete this course.
Daniel C. 15.04.2021
Great writers, professional team who gave me value for my money, I thank you for the great writings!
Douglas B. 16.04.2021
The is the most useful course for me, I have ever attended.
Tegon G. 16.04.2021
I never ordered from this website before.
Kenneth R. 17.04.2021
I think that their best feature is that they explain everything in detail.
Chris M. D. 17.04.2021
It is almost impossible to complete the task without any remarks from the first time, as Im always seeking help with tough tasks.
Ty Y. 18.04.2021
Will happy to come back in future and work with them again.
Mical M. 19.04.2021
I want to thanks all team that worked for this course happening.
Chris F. 19.04.2021
Great course for beginners
Angad C. 20.04.2021
Im in the midst of drafting my dissertation.
Troy E. 21.04.2021
There were a couple of times that I wasnt certain that I fully understood what I was doing, so to have me grade someone else left me feeling unguided and unqualified to assign a grade.
Connor F. 21.04.2021
good for learner to study online
Mark L. 21.04.2021
Helpful and supportive.