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Respondents continue to report that service providers primarily lose bids for bioprocessing efforts due to Regulatory violations / FDA form 483 warnings (49%), their inability to meet required timelines (48%), and high cost (47%). Roughly one-fifth of this year’s survey participants listed regulatory violations and timeline shortcomings as the main reason why a CDMO is not selected (23% and 19%, respectively).
Though service providers may have limited control over regulatory history, operating timelines, price, or capacity in the current environment, bioprocessing CDMOs would be wise to ensure their communication with sponsors is timely throughout the proposal process. Respondents cite Lack of responsiveness as the fifth main reason for lost bids.
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