Outsourcing mixed: case-by-case decisions.
Feedback from biomanufacturing directors also showed that the decision to outsource is made on a case-by-case basis as opposed
to an overall strategic leaning toward outsourcing or keeping manufacturing in-house. Select comments are outlined below:
- "Whether we outsource or not would be driven by our pipeline. Two sources contribute to our pipeline: our in-house R&D and
molecules we acquire in early phases of development. We plan to expand our facilities, but we are conservative in our investments
in GMP facilities. If we have a big project that requires more capacity than we have in-house, we would consider outsourcing
- "Our strategy is a balanced approach between in-house production and outsourcing. In this way we can minimize our risk, and
it gives us maximum flexibility."
- "Up to now, we have been trying to develop the processes ourselves. Now we have identified a few CMOs that can do process
development better than us, and so we are in the process of changing our strategy. We would like to go backwards and let these
CMOs do some process development. Our decision to outsource used to be based solely on volume and demand. Now we also include
quality, technology, and previous experience with that CMO when we decide to farm something out."
- "Cost and time are our main drivers in our biomanufacturing strategy. Our philosophy is to keep flexible. We want to bring
our products into manufacture as soon as possible, so we shuffle what we do in-house, versus outsourcing based on capacity
Demand for expanded outsourcing services
To understand what biopharmaceutical manufacturing directors believe are the most important services to outsource, the survey
asked the directors to list the services that they plan to outsource within the next three years (see Table I). Many of the
biopharmaceutical manufacturing directors would prefer to have their contract manufacturer offer a complete set of services,
rather than dealing with several contractors for individual services. As might be expected, smaller biopharmaceutical companies
with fewer employees and resources and less expertise are especially concerned about the burden of coordinating various service
providers. In addition, some of the larger biopharmaceutical companies recognize that many of the biopharmaceutical contract
manufacturers have areas of expertise that they do not have and are looking to contract manufacturers to provide.
Table I: Services planned to be outsourced during the next three years (1).
The majority of biopharmaceutical contract manufacturers are expanding their service offerings to meet demand for additional
service offerings. Table II shows a list of expanded offerings by the biopharmaceutical contract manufacturers. This list
includes some of the service offerings that were added during the past two years and those that biopharmaceutical contract
manufacturers plan to add in the next two years.
Table II: Select new or planned service offerings of biopharmaceutical contract manufacturers (1) .