Therapeutic Product Immunogenicity Community

Traditionally, long-term stability intervals in ADA are often referenced from white papers derived from stability assessment in vaccine studies. While these provide useful and indirect evidence of ADA stability, direct insight of ADA stability can be obtained from the reanalysis of incurred samples or cross-validation data where the original clinical samples are used for the comparison of different method platforms.

If you have data that provide direct evidence of ADA stability in study samples, could you please share this information with us? We aim to incorporate the findings into an ongoing AAPS white paper focused on the long-term stability of ADA. 

------------------------------
Bonnie Wu Ph.D.
Associate Scientific Director
Janssen Research & Development LLC
Malvern PA
[email protected]

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

Hi Bonnie,

There is direct evidence published by the Novo team 

Stability of anti-drug antibodies in human serum samples - ScienceDirect

(ADAs were stable after 72 h at 22 °C, after 2 weeks at 4 °C, and after 6.3 years at −20 °C)

Do you already have representation from Novo in your team, in case they have additional data that can be contributed...?

Rob

------------------------------
Robert Nelson
Scientific Officer, Senior Director
BioAgilytix Europe GmbH
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer or other entities to which I am affiliated.

Original Message:
Sent: 04-16-2025 17:24
From: Bonnie Wu
Subject: Direct evidence of ADA long-term stability in study samples

Traditionally, long-term stability intervals in ADA are often referenced from white papers derived from stability assessment in vaccine studies. While these provide useful and indirect evidence of ADA stability, direct insight of ADA stability can be obtained from the reanalysis of incurred samples or cross-validation data where the original clinical samples are used for the comparison of different method platforms.

If you have data that provide direct evidence of ADA stability in study samples, could you please share this information with us? We aim to incorporate the findings into an ongoing AAPS white paper focused on the long-term stability of ADA. 

------------------------------
Bonnie Wu Ph.D.
Associate Scientific Director
Janssen Research & Development LLC
Malvern PA
[email protected]

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

Hi Rob,

Thanks for sharing your comments. Beyond this case, we are looking for more direct evidence for ADA long-term stability in the study samples.

My best,

Bonnie

Hi Bonnie,

There is direct evidence published by the Novo team 

Stability of anti-drug antibodies in human serum samples - ScienceDirect

(ADAs were stable after 72 h at 22 °C, after 2 weeks at 4 °C, and after 6.3 years at −20 °C)

Do you already have representation from Novo in your team, in case they have additional data that can be contributed...?

Rob

------------------------------
Robert Nelson
Scientific Officer, Senior Director
BioAgilytix Europe GmbH
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer or other entities to which I am affiliated.

Original Message:
Sent: 04-16-2025 17:24
From: Bonnie Wu
Subject: Direct evidence of ADA long-term stability in study samples

Traditionally, long-term stability intervals in ADA are often referenced from white papers derived from stability assessment in vaccine studies. While these provide useful and indirect evidence of ADA stability, direct insight of ADA stability can be obtained from the reanalysis of incurred samples or cross-validation data where the original clinical samples are used for the comparison of different method platforms.

If you have data that provide direct evidence of ADA stability in study samples, could you please share this information with us? We aim to incorporate the findings into an ongoing AAPS white paper focused on the long-term stability of ADA. 

------------------------------
Bonnie Wu Ph.D.
Associate Scientific Director
Janssen Research & Development LLC
Malvern PA
[email protected]

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

Hi Bonnie,

Here is another one: 

Stability of Anti-Drug Antibodies Against Antibody Therapeutics

https://link.springer.com/article/10.1208/s12248-025-01030-z.

Thanks,

Yi

Hi Rob,

Thanks for sharing your comments. Beyond this case, we are looking for more direct evidence for ADA long-term stability in the study samples.

My best,

Bonnie

Hi Bonnie,

There is direct evidence published by the Novo team 

Stability of anti-drug antibodies in human serum samples - ScienceDirect

(ADAs were stable after 72 h at 22 °C, after 2 weeks at 4 °C, and after 6.3 years at −20 °C)

Do you already have representation from Novo in your team, in case they have additional data that can be contributed...?

Rob

------------------------------
Robert Nelson
Scientific Officer, Senior Director
BioAgilytix Europe GmbH
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer or other entities to which I am affiliated.

Original Message:
Sent: 04-16-2025 17:24
From: Bonnie Wu
Subject: Direct evidence of ADA long-term stability in study samples

Traditionally, long-term stability intervals in ADA are often referenced from white papers derived from stability assessment in vaccine studies. While these provide useful and indirect evidence of ADA stability, direct insight of ADA stability can be obtained from the reanalysis of incurred samples or cross-validation data where the original clinical samples are used for the comparison of different method platforms.

If you have data that provide direct evidence of ADA stability in study samples, could you please share this information with us? We aim to incorporate the findings into an ongoing AAPS white paper focused on the long-term stability of ADA. 

------------------------------
Bonnie Wu Ph.D.
Associate Scientific Director
Janssen Research & Development LLC
Malvern PA
[email protected]

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

Hi Yi,

Thanks for sharing the information. It is great that more evidence has been gathered regarding the stability of ADA in serum matrix in recent years. I am glad to see the ADA stability at -20 C was extended to 6 years. Relevant references will be included in the white paper.

Thank you!

All the best,

Bonnie

Hi Bonnie,

Here is another one: 

Stability of Anti-Drug Antibodies Against Antibody Therapeutics

https://link.springer.com/article/10.1208/s12248-025-01030-z.

Thanks,

Yi

Hi Rob,

Thanks for sharing your comments. Beyond this case, we are looking for more direct evidence for ADA long-term stability in the study samples.

My best,

Bonnie

Hi Bonnie,

There is direct evidence published by the Novo team 

Stability of anti-drug antibodies in human serum samples - ScienceDirect

(ADAs were stable after 72 h at 22 °C, after 2 weeks at 4 °C, and after 6.3 years at −20 °C)

Do you already have representation from Novo in your team, in case they have additional data that can be contributed...?

Rob

------------------------------
Robert Nelson
Scientific Officer, Senior Director
BioAgilytix Europe GmbH
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer or other entities to which I am affiliated.

Original Message:
Sent: 04-16-2025 17:24
From: Bonnie Wu
Subject: Direct evidence of ADA long-term stability in study samples

Traditionally, long-term stability intervals in ADA are often referenced from white papers derived from stability assessment in vaccine studies. While these provide useful and indirect evidence of ADA stability, direct insight of ADA stability can be obtained from the reanalysis of incurred samples or cross-validation data where the original clinical samples are used for the comparison of different method platforms.

If you have data that provide direct evidence of ADA stability in study samples, could you please share this information with us? We aim to incorporate the findings into an ongoing AAPS white paper focused on the long-term stability of ADA. 

------------------------------
Bonnie Wu Ph.D.
Associate Scientific Director
Janssen Research & Development LLC
Malvern PA
[email protected]

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