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European bioanalysis forum recommendations for strengthening bioanalytical method transfer and validation through

Lene Andersen1, Fabian Gaertner2, Sibel Ahmedova3

  • 1Novo Nordisk A/S, Clinical LCMS Bioanalysis, Maaløv, Denmark.

Bioanalysis
|May 24, 2026
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Summary

Successful bioanalytical method transfer relies on strong collaboration and clear communication between pharmaceutical companies and contract research organizations. Focusing on partnership and interaction, rather than just procedures, ensures reliable drug development outcomes.

Keywords:
Bioanalytical method transfermethod validationpharma-CRO collaborationscientific communication

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Area of Science:

  • Pharmaceutical Development
  • Analytical Chemistry
  • Drug Discovery

Background:

  • Bioanalytical method transfer is crucial in drug development but often faces challenges due to poor communication and misalignment between organizations.
  • Technical limitations are rarely the primary cause of transfer failures; instead, issues stem from interpersonal and procedural gaps.

Purpose of the Study:

  • To identify key behaviors influencing the success of bioanalytical method transfer.
  • To provide practical recommendations for enhancing collaboration between pharmaceutical companies and contract research organizations (CROs).

Main Methods:

  • Conducted a multi-table workshop involving pharmaceutical professionals and CRO representatives.
  • Utilized a community survey to gather broader insights on method transfer challenges and successes.

Main Results:

  • Identified critical success factors including early subject matter expert (SME) engagement, shared scientific understanding, proactive communication, joint risk management, and defined responsibilities.
  • Highlighted that successful transfer depends more on a collaborative mindset and deliberate interactions than on rigid procedural adherence.

Conclusions:

  • Emphasizes the importance of a partnership approach and effective communication for predictable and reliable bioanalytical method transfer.
  • Recommends focusing on behavioral principles over templates to foster scientific convergence and strengthen inter-organizational collaboration.