ACS GCI Pharmaceutical Roundtable

ACS GCI Pharmaceutical Roundtable—Catalyzing green chemistry & engineering in the global pharmaceutical industry.

API Biodegradation

Team Leads

 

Tobias Harschneck
Tobias Harschneck
Boehringer Ingelheim Vetmedica GmbH
Tony Reed
Tony Reed
Amgen

Team Members

Chengli Zu, Sanjay Menon, Jovan Livado, Gemma Liwicki, Tobias Harschneck, Rich Girasole, Julie Boberg, Eva Vestergaard, Michael Lo, Tessa Scown, Daneil Hunziker, Malte Mikus, Shibin Li, Gemma Janer, Irene Bramke, Silvio Roggon.

Goal

Develop practical workflows and tools to measure and predict API biodegradation and persistence, then share these with medicinal chemists who can then choose environmentally benign clinical candidates.

Team Folder

DMS

Team Status

Updated: March 2024

Achievements

Phase I 

  • Educate team on current state (AgChem, Animal Health, & Human Pharma):
    • Preliminary and regulatory assays
    • Predictive tools
  • Discover common ground – differences, pain points and gaps of current tools

Challenges

  • Take into account the reluctance to add additional roadblocks towards compound advancement; make sure the tools created do not impede project success
  • Discern whether the ultimate goal is realistic with state-of-the-art: publish either way

Activity Snapshot

Phase Ib

  • External speakers have been invited to educate the team on technology and tools
    • Adriano Joss – EAWAG (WWTP function) – October 2023
    • Kathrin Fenner – EAWAG (Biodegradation Assays) – March 2024
    • Jakub Kostal – GWU (Computational Tools) – April 2024
    • Russell Davenport – Newcastle University (Biodegradation Assays)
    • Chris Slootweg – U of Amsterdam (General Concepts)

GC&E Symposium – June 2024, Atlanta, GA

Upcoming Projects

Phase II

  • Find and/or develop tools (through grants) to measure & predict biodegradation potential of molecules
  • Develop, update, and communicate decision tree

Phase III

  • Communicate compound selection decision tree (publication, talks, internal sharing)
  • Suggest types of treatments which are in scope: chronic vs acute treatment, first-to-market vs follow-on
  • Suggest how to use decision tree as part of selection criteria (as opposed to design cycles)
  • Make case for why to use – 1) benefit to environment and 2) practical tools will not impede discovery
  • Solicit feedback from broader community for benefits of decision tree – make refinements based on feedback