It is a good idea to collect feedback on ADA LTS testing in non-blood matrix. I will find out whether we can add this question to the survey. Meanwhile, if you have performed ADA LTS testing in non-blood matrix, you can provide your feedback in question #12.
Original Message:
Sent: 10-08-2023 12:47
From: Ritankar Majumdar
Subject: Survey for Anti-Drug Antibody Long-Term Stability Testing
Hi @Bonnie Wu,
Could I suggest that we add non-blood matrix testing to the survey as well? For example, what is the industry's standing on ADA testing in CSF, breast milk etc. There are few white papers and position documents on ADA stability in plasma and serum, but I am not aware if similar literature is present for other matrices
Thank you
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Ritankar Majumdar
Team Lead,
Ichem BioA
LabCorp Drug Development
[email protected]
[email protected]
[email protected]
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
Original Message:
Sent: 10-04-2023 18:43
From: Bonnie Wu
Subject: Survey for Anti-Drug Antibody Long-Term Stability Testing
Dear AAPS Therapeutic Product Immunogenicity Community Members,
I have worked with some AAPS folks to put together a survey for ADA long-term stability (LTS) testing. This survey is designed to evaluate current practice and the results from ADA LTS testing during ADA assay method validation. The information will help industry sponsors and regulators understand the current approaches taken on ADA LTS assessment.
I would like to circulate the survey link so that scientists working on ADA assay validation can provide feedback to facilitate future discussions on this topic. To avoid redundancy, each sponsor should have one representative complete the survey.
The survey link is provided below. I look forward to the feedback and responses from the industry colleagues. For sponsors who don't conduct ADA LTS testing, your feedback on relevant questions would also be valuable for us to understand your justifications for ADA LTS practice that would provide important information to facilitate the alignment among industry sponsors and regulatory agencies.
Anti-Drug Antibody Long-Term Stability Testing (surveymonkey.com)
Thank you in advance for sharing your feedback!
Kind regards,
Bonnie
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Bonnie Wu Ph.D.
Associate Scientific Director
Janssen Research & Development LLC
Spring House PA
[email protected]
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