Case Study

AstraZeneca – Integrating human and environmental health in antibiotic risk assessment

Sub category of Industry R&D Pharma
Category of commitment Manufacturing
Which product(s) Small molecule
Key focus Responsible Manufacturing
Key partners of the program Academia & think tanks, Governments
Geographic focus Global

Health needs

Antibiotics are vital in the treatment of bacterial infectious diseases but when released into the environment they may impact non-target organisms that perform vital ecosystem services and enhance antimicrobial resistance development with significant consequences for human health. In order to manage AMR associated with antibiotic containing manufacturing effluents effectively, science-driven, risk-based targets for discharge concentrations for antibiotics are required. AstraZeneca reviewed all publicly available clinical and environmental effects data for antibiotics to help inform their AMR Roadmap commitments on manufacturing emissions.

Initiative’s objective

Effective environmental risk assessment regulatory guidance should be informed by science-based protection goals for antibiotic manufacturing discharges.

Initiative’s description

AstraZeneca established a programme to help identify environmental protection goals that could be applied to antibiotic production facilities as part of their UN AMR Roadmap Commitments, fully funding ($140K) a four-year PhD student with the University of Exeter to analyse all existing public environmental and clinical data assessing the impact of antibiotics. AstraZeneca are using the results to help inform their strategies to fill existing antibiotic data gaps and refine the way that antibiotics environmental risks are currently assessed.

Through this work AstraZeneca have highlighted the following as key considerations for the use, and development of human and ERA frameworks for antibiotics.

  • The need for inclusion of a larger selection of bacterial species for testing to account for the variability in sensitivity between species and for greater confidence in the protection of bacterial communities and the ecosystem services they provide.
  • Test systems to determine Predicted No Effect Concentrations or Minimum Selective Concentrations (MSC) for AMR development are urgently required for clinical and environmental species.
  • A discharge limit of 100 ng/L maybe a protective and pragmatic approach to address environmental concerns around antibiotic production in the absence of sufficient reliable clinical and environmental data, whilst urgently needed methodologies and empirical data are obtained to draw firmer conclusions. Where data exists that suggest a higher or lower concentration is required to be protective that value should be used instead.

Lessons for success

There are too few environmental data in the public domain and many antibiotics authorisation pre-date the need for an environmental risk assessment thus making it difficult to establish protection goals for all antibiotics. This may require additional targeted testing for these antibiotics or the use of an interim protective level or metric in the absence of data.