By Kevin Sharp, Samsung Biologics
Outsourcing has become an attractive business model for pharma companies to expedite projects by contracting out all or part of their product development, clinical trials, and/or manufacturing through commercialization. In turn, rising demand for CDMO partners that deliver end-to-end services has pushed global pharmas to expand their service scopes and, in some cases, to upgrade their facilities and add manufacturing capacity.
In this competitive landscape, finding the right CDMO (i.e. a partner that meets a project’s criteria, is “right-sized,” and/or that has the capacity to produce a given product) for an Active Pharmaceutical Ingredient (API) development or manufacturing project has become more difficult. Accordingly, planning a CDMO search based on a foundation for long-term success often is the difference between a program plagued by difficulties (e.g. cost overruns and delays) and one that thrives.
Among larger biopharma sponsors, we see greater focus and attention paid to commercialization of their products. Whether they seek a CDMO partner at the early stages of cell line development, during clinical trials, or once it is time for commercial-scale manufacture, commercialization almost always is the ultimate goal. So, every step along that pathway, from production processes to materials procurement, is considered within the context of commercialization of that product.
Within smaller organizations, the next milestone often is the ultimate goal, with concern for subsequent milestones considered “back-burner” until the project’s advancement is assured. Thus, capacity issues often relate to a lack of short-term capacity availability. In this common scenario, a CDMO that can provide insight regarding how current activities impact subsequent steps can be invaluable (in addition to providing capacity).
In any situation, a CDMO’s ability to react to a changing program and scale-up needs is critical.