Biologics, often referred to as biopharmaceuticals or large molecules, are manufactured in the biological system, such as microorganisms, plants, or animal cells. Biologics contract manufacturing organizations represent one of the fastest growing segments of the pharmaceutical industry. This can be attributed to the rapid pace of innovation in this field, driven by the need for effective and personalized pharmacological interventions. Currently, biopharmaceutical companies are embracing a business model, as per which, some activities, such as R&D of drugs, are being initiated by them; however, for the development process, players are still seeking the help of multiple external research service providers. These external research service providers are various biopharma contract research organizations (CRO). The United States Food and Drug Administration (USFDA), states that CRO is a person that assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor, for instance design of a protocol, selection or monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the USFDA. Some of research services that are commonly offered by a biopharma CRO are shown in figure.
Key advantages offered by biopharma CRO includes time efficiency, cost effectiveness, key to innovation, and quality innovation. Despite the advantages offered, there are some risks associated with outsourcing research activities to biopharma CRO such as loss of confidentiality issues, compromised quality, de-prioritization, delayed timelines, risks associated with subcontracts. The process of selecting a suitable biopharma CRO partner is also critical to a project’s success. The key parameters that need to be considered while selecting a biopharma CRO partner are represented in figure.