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In a guest column Kevin Wall, principal consultant and owner of Cincero Consulting, emphasizes the critical importance of selecting the right Contract Development and Manufacturing Organization (CDMO) for drug product development. Small and virtual pharmaceutical companies often outsource their product and process development, making the selection of a competent CDMO vital for their overall success.
Wall highlights three essential questions that should be considered when choosing a CDMO:
1. Adequate Human Capital: Wall emphasizes that the success of any project depends on the expertise and capacity of the people executing it. While a compliant Quality Management System (QMS) and state-of-the-art facilities are important, it is the competence and decision-making ability of the people running the CDMO that have the most significant impact. Therefore, evaluating the skills and capacity of the CDMO’s team members is crucial for making a wise decision.
2. Quality Risk Management: Quality by Design is now expected in regulatory submissions, and CDMOs often highlight their approach to it during sales presentations. However, Wall advises companies to go beyond buzzwords and assess the substance behind these claims. A well-documented, risk-based approach to equipment qualifications, cleaning validation, and facility monitoring should be evident. Tangible examples of how the CDMO identifies critical process variability and executes risk-based analyses are key indicators of their understanding and application of risk management principles.
3. Analytical Development: Wall emphasizes that analytical development is a critical aspect that can significantly impact project timelines. The validity of analytical methods directly influences product characterization, investigations, regulatory submissions, and more. Proper execution of analytical transfer, sufficient bandwidth and expertise for generating chemical markers, and the ability to handle reference standards are key factors to consider when evaluating a CDMO’s analytical development capabilities.
In conclusion, Wall emphasizes that selecting the right CDMO is a pivotal decision for any pharmaceutical development timeline. Investing in a competent CDMO with a well-rounded team and a solid understanding of quality risk management can significantly contribute to a project’s success and, ultimately, the company’s overall success.