CDMO Outsourcing Trends in the Development and Manufacturing of Biologics
Outsourcing the development and manufacturing of biologics to a contract development and manufacturing organization (CDMO) has many advantages including speed, flexibility, and risk mitigation.
In 2021, we conducted a global market research survey with small, mid-sized, and large biopharmaceutical companies across the United States, Europe, and Asia developing monoclonal antibody therapies. The 40+ responders represent those with job functions ranging from process development, operations and manufacturing, executive management, and quality. All respondents were knowledgeable about working with CDMOs. Below are the key takeaways from the survey.
Demographic, representation, and job functions of the 40+ respondents to our 2021 global market research survey.
Survey respondents were from biopharmaceutical companies with representation from the United States, Europe, and Asia.
Respondents were knowledgeable about working with contract development and manufacturing organizations.
Process development, operations/manufacturing, executive management and quality
Pre-clinical Outsourcing and Commercial Outsourcing Have Different Drivers
During the pre-clinical phase, the main reason for outsourcing drug development and/or manufacturing is risk mitigation, speed, and end-to-end capabilities. A CDMO with comprehensive end-to-end expertise and capabilities means that all activities from process and analytical development through clinical and commercial scale production can be housed under “one roof.”
In contrast, once in the commercial phase, adaptability to scale and production slot availability were the main drivers. Adaptability is especially important at the beginning of the commercialization phase (ex: first year) as the market is not fully established and parameters such as prescribing habits, variation in dosage, and the presence of new competitors impact demand. After the first year, priorities shift from adaptability to efficiency and cost saving.
CDMOs Should Support Flexibility During the Pre-clinical Phase
At the pre-clinical phase, templating and custom solutions are both key drivers in CDMO selection. It’s common for CDMOs to leverage pre-defined templates to streamline workflows, but it’s also important that that template can be tailored to meet specific needs of the molecule or the timeline. Custom solutions are important for difficult to express molecules. These approaches and short timelines are best balanced with tailored risk mitigation strategies.
Flexibility and Measured Risk Taking Are Still Important During the Commercial Phase
Our survey shows that taking risks to progress faster in important in commercial stages. Thus, a CDMO should take into account the client’s past experiences during the pre-clinical and clinical phases to adapt it to the CDMO facility, scale it, and validate it.
Single-use Technology is Preferred for Monoclonal Antibody Processes
Our global survey found that 41% of companies expect to increase their usage of single-use equipment in the future. As flexibility in terms of scale is an important benefit of single-use technologies, a CDMO that uses these technologies can be fast and responsive to change. A CDMO that uses single-use technologies means standardization and simpler operations which can ease the tech transfer process from the CDMO back to the customer if they decide to take production in-house.
CDMOs Should Balance Speed and Risk
Working with a CDMO can help drug manufacturers overcome many hurdles: balancing risk and speed, managing unpredictable, ever-changing priorities, forecasting market demands, accessing multiple sources of expertise, and more. Out of these hurdles, our survey showed that the most important factor for drug manufacturers is balancing risk and speed.
Project Management is Among the Most Important Elements of the CDMO Partnership
In our survey, we asked what is the most important element for a CDMO partner. Out of many options, 57% of our respondents ranked robust and transparent project management as their number one priority.
To see our in-depth analysis of these CDMO trends and to get the perspective from our experts, download our whitepaper or watch our webinar.
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