Biomarkers and Precision Medicine Community (BPMC)

Meeting Report:

In the December PK Methodology Working Group meeting, Dr. Dawn Dufield from KCASBIO presented and led the discussion on the validation of PK Hybrid LCMS methods:

• Overview of Hybrid LCMS - definition
• When to use Hybrid vs LBA  - Advantages/disadvantages
• Case Studies - highlighting scientific examples and validation data - using new ICH M10 guidance extended to Hybrid
  • ADC - Total Ab and ADC conjugate in single assay – validation of a preclinical assay using a receptor IP
  • ADC - Total Ab and ADC - cleavable payload - single sample split into two workflows post IP using an anti-human IgG IP
  • Transgene protein expression - an example where validation was not recommended - no proper reference standard - used fit-for-purpose qualification approach.

The monthly gathering of the PK Assay Working Group, focusing on PK Methodologies for Biologics, Cell, and Gene therapies, provides an invaluable platform for industry experts to come together. During these meetings, we collaboratively share best practices, tackle emerging challenges, and exchange valuable experiences. The primary goal is to support each other in refining PK methodologies and facilitating successful filling and submission processes.

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Mark Ma Ph.D.
VP. Head of Translational Clinical Sciences
Rallybio
New Haven CT
[email protected]

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

Thanks for sharing this meeting report. I would like to learn more about Dr. Dawn Dufield's presentation. If it was recorded, do you mind sharing the link?

Also, I am interested in joinin the PK Methodology Working Group. Do you mind share how I can join you? 

Thank you  and best regards,

Gordon Gu

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Gordon Gu
Associate Director, Bioanalysis
Larimar Therapeutics
Bala Cynwyd 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: 12-12-2023 08:52
From: Mark Ma
Subject: Meeting report: Validation of PK Hybrid LCMS Methods.

Meeting Report:

In the December PK Methodology Working Group meeting, Dr. Dawn Dufield from KCASBIO presented and led the discussion on the validation of PK Hybrid LCMS methods:

• Overview of Hybrid LCMS - definition
• When to use Hybrid vs LBA  - Advantages/disadvantages
• Case Studies - highlighting scientific examples and validation data - using new ICH M10 guidance extended to Hybrid
  • ADC - Total Ab and ADC conjugate in single assay – validation of a preclinical assay using a receptor IP
  • ADC - Total Ab and ADC - cleavable payload - single sample split into two workflows post IP using an anti-human IgG IP
  • Transgene protein expression - an example where validation was not recommended - no proper reference standard - used fit-for-purpose qualification approach.

The monthly gathering of the PK Assay Working Group, focusing on PK Methodologies for Biologics, Cell, and Gene therapies, provides an invaluable platform for industry experts to come together. During these meetings, we collaboratively share best practices, tackle emerging challenges, and exchange valuable experiences. The primary goal is to support each other in refining PK methodologies and facilitating successful filling and submission processes.

------------------------------
Mark Ma Ph.D.
VP. Head of Translational Clinical Sciences
Rallybio
New Haven CT
[email protected]

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