Biopharmaceutical Product Attributes and Biological Consequences Community

BPABC Colleagues,

Even though I've not been posting any details about this I am happy to inform everyone that the Cross-Lab Study that originated within this Community has officially begun and NIST and Amgen have been sending out mAb samples to all of the participants for the analytical phase of the study. 

Due to legal reasons, I have not been able to share the details of the study or stress conditions with the entire Community but the participants who have signed the MTAs are aware of the details.  If any of you, who are not involved at this point, would like to get involved for the second phase of the study where we will look into the biological consequences of the stressed material and assess variability of the in-vitro and/or in-vivo assays, please reach out to me ([email protected]).  We are planning to have a meeting to recruit folks for this aspect of the study later this fall. 

Many thanks,

Srivalli

------------------------------
Srivalli Telikepalli Ph.D.
Research Chemist
National Institute of Standards and Technology
Gaithersburg MD
[email protected]

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

Years of planning, rigorous scientific discussions and hard work aligning the study plan, assays, material generation, deliverables and other logistical aspects! Thanks to the scientists from many organizations who signed up for the first phase. 

So glad to see the progress. Second phase will be equally exciting to study the biological consequences. 

Thanks for your leadership, Srivalli.

BPABC Colleagues,

Even though I've not been posting any details about this I am happy to inform everyone that the Cross-Lab Study that originated within this Community has officially begun and NIST and Amgen have been sending out mAb samples to all of the participants for the analytical phase of the study. 

Due to legal reasons, I have not been able to share the details of the study or stress conditions with the entire Community but the participants who have signed the MTAs are aware of the details.  If any of you, who are not involved at this point, would like to get involved for the second phase of the study where we will look into the biological consequences of the stressed material and assess variability of the in-vitro and/or in-vivo assays, please reach out to me ([email protected]).  We are planning to have a meeting to recruit folks for this aspect of the study later this fall. 

Many thanks,

Srivalli

------------------------------
Srivalli Telikepalli Ph.D.
Research Chemist
National Institute of Standards and Technology
Gaithersburg MD
[email protected]

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

Years of planning, rigorous scientific discussions and hard work aligning the study plan, assays, material generation, deliverables and other logistical aspects! Thanks to the scientists from many organizations who signed up for the first phase. 

So glad to see the progress. Second phase will be equally exciting to study the biological consequences. 

Thanks for your leadership, Srivalli.

BPABC Colleagues,

Even though I've not been posting any details about this I am happy to inform everyone that the Cross-Lab Study that originated within this Community has officially begun and NIST and Amgen have been sending out mAb samples to all of the participants for the analytical phase of the study. 

Due to legal reasons, I have not been able to share the details of the study or stress conditions with the entire Community but the participants who have signed the MTAs are aware of the details.  If any of you, who are not involved at this point, would like to get involved for the second phase of the study where we will look into the biological consequences of the stressed material and assess variability of the in-vitro and/or in-vivo assays, please reach out to me ([email protected]).  We are planning to have a meeting to recruit folks for this aspect of the study later this fall. 

Many thanks,

Srivalli

------------------------------
Srivalli Telikepalli Ph.D.
Research Chemist
National Institute of Standards and Technology
Gaithersburg MD
[email protected]

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

Hi Ritankar,

We have slides and a legal document (MTA) in place that describes this.  I can share the slides with you if you are interested.  

Best,

Srivalli

Years of planning, rigorous scientific discussions and hard work aligning the study plan, assays, material generation, deliverables and other logistical aspects! Thanks to the scientists from many organizations who signed up for the first phase. 

So glad to see the progress. Second phase will be equally exciting to study the biological consequences. 

Thanks for your leadership, Srivalli.

BPABC Colleagues,

Even though I've not been posting any details about this I am happy to inform everyone that the Cross-Lab Study that originated within this Community has officially begun and NIST and Amgen have been sending out mAb samples to all of the participants for the analytical phase of the study. 

Due to legal reasons, I have not been able to share the details of the study or stress conditions with the entire Community but the participants who have signed the MTAs are aware of the details.  If any of you, who are not involved at this point, would like to get involved for the second phase of the study where we will look into the biological consequences of the stressed material and assess variability of the in-vitro and/or in-vivo assays, please reach out to me ([email protected]).  We are planning to have a meeting to recruit folks for this aspect of the study later this fall. 

Many thanks,

Srivalli

------------------------------
Srivalli Telikepalli Ph.D.
Research Chemist
National Institute of Standards and Technology
Gaithersburg MD
[email protected]

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