An interlaboratory transfer of a multi-analyte assay between continents

Area of Science:

• Pharmaceutical Sciences
• Analytical Chemistry
• Drug Development

Background:

• Bioanalytical and toxicokinetic studies are critical throughout drug development.
• Outsourcing bioanalysis to Contract Research Organizations (CROs) is a common strategy.
• Ensuring data quality and regulatory compliance during assay transfer is paramount.

Purpose of the Study:

• To highlight the challenges encountered during bioanalytical assay transfer and cross-validation between laboratories.
• To emphasize the importance of planning and communication in overcoming these challenges.
• To illustrate best practices for successful assay transfer and validation in a global context.

Main Methods:

• Case study approach detailing assay transfer and cross-validation processes.
• Focus on technical and logistical challenges in inter-laboratory assay transfer.
• Examination of investigation procedures following failed cross-validation.

Main Results:

• Assay transfer and cross-validation between different laboratories, especially across continents, can be complex.
• Technical and logistical hurdles can significantly impact timelines and data reliability.
• Successful transfer requires robust planning, effective communication, and rigorous investigation protocols.

Conclusions:

• Effective assay transfer and cross-validation are essential for maintaining data integrity in drug development.
• Proactive planning and open communication between all parties are critical for mitigating risks.
• This case study underscores the necessity of a systematic approach to ensure quality bioanalytical data from outsourced studies.