Therapeutic Product Immunogenicity Community

Neutralization Activity of Anti-drug Antibodies Against a Biotherapeutic Can Be Predicted from a Comprehensive Pharmacokinetics, Pharmacodynamics, and Anti-drug Antibody Data Analysis - The AAPS Journal SpringerLink remove preview Neutralization Activity of Anti-drug Antibodies Against a Biotherapeutic Can Be Predicted from a Comprehensive Pharmacokinetics, Pharmacodynamics, and Anti-drug Antibody Data Analysis - The AAPS Journal Historically, a neutralization antibody (NAb) assay is considered critical in immunogenicity assessment of biologic therapeutics, even with low anti-drug antibody (ADA) positive rates. In 2019, FDA new guidelines issued on immunogenicity testing acknowledged the possibility of using "a highly sensitive PD marker or an appropriately designed PK assay or both that generate data that inform clinical activity" to replace a NAb assay. View this on SpringerLink >

To view the full article through your AAPS membership:

Go to https://www.aaps.org/education-and-research/journals/the-aaps-journal 

Enter your AAPS credentials

Click "Member Access to Journals"

Click on the The AAPS Journal cover.

Copy and paste the url into the "Search" box, and click search

The full article should appear.

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Ho-Leung Fung Ph.D., FAAPS
Editor-in-Chief
University at Buffalo
Sarasota FL
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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Thanks Dr. Fung for recommending the paper!

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Weifeng Xu
Director
Merck
West Point PA
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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Original Message:
Sent: 10-08-2022 09:21
From: Ho-Leung Fung
Subject: New AAPS Journal article of possible community interest

Neutralization Activity of Anti-drug Antibodies Against a Biotherapeutic Can Be Predicted from a Comprehensive Pharmacokinetics, Pharmacodynamics, and Anti-drug Antibody Data Analysis - The AAPS Journal SpringerLink remove preview Neutralization Activity of Anti-drug Antibodies Against a Biotherapeutic Can Be Predicted from a Comprehensive Pharmacokinetics, Pharmacodynamics, and Anti-drug Antibody Data Analysis - The AAPS Journal Historically, a neutralization antibody (NAb) assay is considered critical in immunogenicity assessment of biologic therapeutics, even with low anti-drug antibody (ADA) positive rates. In 2019, FDA new guidelines issued on immunogenicity testing acknowledged the possibility of using "a highly sensitive PD marker or an appropriately designed PK assay or both that generate data that inform clinical activity" to replace a NAb assay. View this on SpringerLink >

To view the full article through your AAPS membership:

Go to https://www.aaps.org/education-and-research/journals/the-aaps-journal 

Enter your AAPS credentials

Click "Member Access to Journals"

Click on the The AAPS Journal cover.

Copy and paste the url into the "Search" box, and click search

The full article should appear.

------------------------------
Ho-Leung Fung Ph.D., FAAPS
Editor-in-Chief
University at Buffalo
Sarasota FL
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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