The global pharmaceutical industry outsourced an estimated $65 billion in drug manufacturing volume to contract manufacturing organizations (CMOs) in 2016, according to the research firm Mordor Intelligence. Pharmaceutical companies contract out to CMOs to reduce capital expenditures and the costs of manufacturing, to gain access to specialized manufacturing methods, and to gain redundant capacity to mitigate the risk of supply interruptions or unanticipated spikes in demand.
The advantages of contract manufacturing come with certain practical risks. Many of those risks are associated with inadequate communication and knowledge transfer between the drug’s originator and the CMO. Most can be minimized.
Throughout this paper on CMO risk mitigation, we will approach the subject from the perspective of a sterile drug product CMO. The principles are equally applicable to other dosage forms, as well as in API manufacturing. Our focus will be to establish methods to reduce project risks when moving from the laboratory to a GMP manufacturing setting.