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The biopharmaceutical contract manufacturing industry continues to expand, as pharmaceutical and biotechnology companies (the users) develop manufacturing strategies to outsource production. Choosing the right biopharmaceutical contract manufacturing organisation (CMO) is a critical decision, with many factors to consider. Further complicating the user’s choice are the vast number of ‘unknowns’ associated with product and process development. The difficulty of switching CMO partnership makes the choice of a CMO critical. The high cost of switching leads most users to view the selection of their CMO as a commitment to a long-term relationship. This article will review the criteria used by biotechnology and pharmaceutical companies to evaluate CMOs, including price, quality and capabilities, and will also examine the ‘softer’ issues pharmaceutical and biotechnology companies need to consider when deciding which CMO to use.
KEY SELECTION CRITERIA
In a report produced in 2009, directors of biomanufacturing at pharmaceutical and biotechnology companies worldwide were interviewed about CMO selection. Outsourcing is part of the production strategy for all respondents in the study.
The directors rated the four most important criteria in selecting a CMO. The responses are categorised by most mentioned without regard to ranking, summarised in Figure 1. As noted, the most mentioned criteria are price, proven capabilities, quality and technical expertise.
TOP CRITERIA
The most mentioned criterion noted by the biomanufacturing directors in choosing a biopharmaceutical contract manufacturer is price. However, the majority of biomanufacturing directors ranked it lower than other factors for choosing a CMO. The key criteria for choosing a CMO were quality, proven capabilities, capacity, technical expertise and technical fit (see Figure 2). |
