In our discussions with biomanufacturing directors about CMO service, their comments are categorized either as service levels or service offerings. Service levels sought by the biomanufacturing directors include flexibility, low cost, high quality, and on-time performance. For the most part, these are service levels where the biomanufacturing directors look for continuous improvement from their CMO. For service offerings, the biomanufacturing directors look for CMOs that can offer fill-and-finish services, process development, cell line development and analytical development.
Below are selected comments from biomanufacturing directors regarding service offerings by their CMO. They need to be flexible with changes in process and timing, have strong project management, and low cost. Drug production is what we need, we crystallize the material with organics, freeze-dry it, etc. For example, if the process development group finished more things than anticipated and we had the opportunity to press forward with manufacture, but not enough capacity, or if research provided more projects for process development than we could handle, then we might look to outsource.
In addition to the current services offered by CMOs, biomanufacturing directors are always looking for additional services from their CMOs. Product specific expertise or platforms, fill-and-finish services, process or analytical characterization, capacity, cell services and formulation are new services sought by biomanufacturing directors Figure 3.
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Not surprisingly, directors from one and zero biomanufacturing site tend to be looking for greater range of new services as compared to those directors from multiple biomanufacturing sites. Below are selected comments from biomanufacturing directors.
We would prefer not to have to use a third-party. There are only a few specialized companies that can manufacture and fill them.
Only large companies can justify building their own fill-and-finish capabilities. We are looking for a contractor that can do conjugation of potent cytotoxins to monoclonal antibodies and offers fill-and-finish services.
That is a little different from what we normally contract for. We are also looking for analytical characterization. The overall biopharmaceutical contract manufacturing has declined from its peak in as a result of the downturn in economic activity and distressed financial markets. These short-term results are not indicative of the longer term trends. The market for outsource services will continue to expand as pharmaceutical and biotechnology companies continue to use CMOs for the production of their biologics.
In addition, biomanufacturing directors are looking to their CMOs to offer other services including fill- and-finish, process development and analytical development services.
And there will always be projects that are best served by domestic suppliers for logistical or strategic reasons. However, data continues to indicate that there is a growing trend towards successful outsourcing to emerging markets, which is something all companies should consider in their long-term positioning strategies.
Survey Methodology: The Nice Insight Pharmaceutical and Biotechnology Survey is deployed to outsourcing-facing pharmaceutical and biotechnology executives on an annual basis.
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