Meeting report of the second European biotransformation workshop

Abstract

Challenges and opportunities in the field of biotransformation were presented and discussed at the 2nd European Biotransformation workshop which was conducted virtually in collaboration with the DMDG on November 24/25, 2021. Here we summarise the presentations and discussions from this workshop.

The following topics were covered:

1. Regulatory requirements and biotransformation studies for antibody drug conjugates (ADCs) and antisense oligonucleotides (ASOs).

2. Solutions for mass spectral data processing of peptides and oligonucleotides.

3. Future outsourcing needs in biotransformation for new modalities.

4. Established quantitative and qualitative workflows for metabolite identification.

5. New in vitro systems to study new chemical entities (NCEs) with low metabolic turnover.

6. New strategies on the timing of the human ADME (absorption, distribution, metabolism, excretion) study and to investigate the impact of human microbiome on drug development.

Keywords:

• Biotransformation of new modalities
• antibody drug conjugates
• antisense oligonucleotides
• metabolite quantitation and qualification
• microphysiological systems
• human ADME
• microbiome

Acknowledgement

The organizers would like to extend their gratitude to all presenters (Georges Da Violante, Christian Lanshoeft, Mark Savage, Andreas Brink, Xueqing Li, Bridget Becker, Dan Weston, Ursula Müller-Vieira, Ester Tor Carreras, Kenichi Umehara, Bernard Walther, Graeme Young), to all additional panel discussion members (Ari Tollonen, Jelle Reinen, Caroline Andersson) and to all participants for fruitful discussions. We would like to acknowledge also the DMDG organising and technical team, in particular Stuart Hex and Chris Barron (AssociAction Enterprises). Without their support, this virtual event would have not been possible. At last, the organizing committee of the European Workshop dedicates the publication of this conference report to Lars Weidolf for the occasion of his retirement from the industry after an impressive career spending more than 42 years at AstraZeneca.

Disclosure statement

The authors report no conflict of interest.