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. According to a December 2023 report, the sterile injectable drugs contract manufacturing outsourcing market is expected to exceed $24.2 billion in 2024. Pharmaceutical companies contract out to CMOs (or CDMO’s like Singota Solutions – a leading Bloomington, Indiana CDMO) for risk mitigation, 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 ( Risk Mitigation ).
Effective project management and alignment with regulatory standards are critical for CMOs to successfully navigate the risks associated with contract manufacturing. By employing well-structured project timelines, clear deliverables, and regular check-ins with clients, CDMOs like Singota Solutions ensure that projects move seamlessly from the initial phases to full-scale GMP production. This organized approach not only keeps projects on schedule but also allows for flexibility in responding to unexpected challenges, such as changes in regulatory requirements or modifications in client specifications. With a commitment to adaptability and continuous improvement, Singota’s team prioritizes communication and transparency throughout each stage.
Additionally, Singota Solutions emphasizes the importance of thorough documentation and data management in mitigating risks within the contract manufacturing process. By implementing advanced quality control systems, data tracking tools, and consistent knowledge-sharing practices, Singota ensures that essential information is seamlessly transferred between teams and maintained throughout the project lifecycle. This diligence in documentation supports compliance with stringent regulatory guidelines, while enabling smoother transitions between project phases. Ultimately, by focusing on these foundational practices, Singota Solutions is able to reduce the inherent risks of contract manufacturing and deliver high-quality, dependable results to their partners in the pharmaceutical industry.
Throughout this paper on CMO risk mitigation, we will approach the subject from the perspective of a sterile drug product CMO. Our focus will be on the essential components such as small batch aseptic filler, aseptic manufacturing solutions (aseptic filling), and cold chain pharmaceutical storage. We’ll also delve into the significance of a GMP compliant warehouse in ensuring quality control. The principles discussed 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, with a particular emphasis on injectable formulation development.