Home » January / February 2022 » Experiencing the evolution of ADC payloads towards extremely complex molecules from a development and manufacturing perspective – A CDMO opinion
2022 | January / February 2022

Experiencing the evolution of ADC payloads towards extremely complex molecules from a development and manufacturing perspective – A CDMO opinion

by cyb2025
A. Terraneo
ADC
CDMO. HPAPIs
Development
linker
payload
QbD

ALBERTO TERRANEO
Cerbios Pharma SA, Lugano, Switzerland

ABSTRACT

Antibody drug conjugates have evolved enormously from their first inception. The linker, while devoid of pharmaceutical activity, has been recognized to play a major role in the safety and efficacy of the whole ADC system. Therefore, great efforts have been spent to improve the pharmacological and biological properties of this fundamental part of ADC. Nevertheless, this has come at the expense of molecular complexity of the linker-toxin, which are now very large molecules, with tens of defined stereocenters, very flexible structures and highly hydrophilic functional groups. The technical issues, and the demanding timeframes of innovators to get to the BLA, require a modern approach for the chemical process development, very different that for small molecules. Quality by Design to prioritize the issues to address, extensive use of preparative HPLC as main control strategy, tangential flow filtration and lyophilization for recovery are the keys to the successful development and production of the most recent linker-payloads.

THE AGE OF ADCs
The year 2021 saw the approval of the eleventh Antibody Drug Conjugate (ADC) by the US Food and Drug Administration: Zynlonta. The recent approvals and more than one hundred and fifty of other ADCs currently undergoing clinical trials, demonstrate the great interest and work ongoing in this field (1-3).

ABOUT THE AUTHOR

Alberto Terraneo holds a PhD in organic chemistry from University of Milan; after almost twenty years covering responsibility roles in CROs focused on chemical process and analytical development, in 2019 he moved into chemical pharmaceutical CDMO. He is now the R&D director of Cerbios Pharma SA, responsible for the chemical and biotechnological research and development activities for the company. During free time he enjoys reading, hiking and rock climbing.

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