The use of biologics is rapidly increasing as new drugs are approved for label expansions. Monoclonal antibodies, multispecific antibodies, and antibody-drug conjugates (ADCs) are being implemented in an array of fields, including oncology, immunology, and neurology. As clinical demand for biologics increases, biopharmaceutical companies must ensure that they have the manufacturing capacity available to produce enough biologics. Creating adequate capacity for any therapeutic can be challenging, and the specialized technologies for manufacturing complex biologics require flexibility and agility in production processes. I will discuss how contract development and manufacturing organizations (CDMOs) ensure that biopharmaceutical companies have a partner with the speed, flexibility, and expertise necessary for successful drug development and manufacturing.
Challenges of in-house capacity
Fortune Business Insights estimates the global value for next generation biomanufacturing will be close to $40 billion by 2033. As the industry prepares for a period of growth, there is a desire to increase productivity and efficiency in biologics manufacturing. But as the biologics become more complicated, maintaining or increasing production efficiency becomes more difficult. Each class of biologics brings its own challenges, ranging from supply chain logistics to complex chemistry that must be consistent between batches.
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Additionally, new manufacturing facilities take time and money to build. The Pharmaceutical Research and Manufacturers of America (PhRMA) calculates that it typically costs $2 billion and five to ten years to finish constructing, staffing, and certifying a new manufacturing facility. If companies opt for in-house manufacturing, these extended construction times require biopharmaceutical companies to begin building plants while clinical trials for promising therapies are underway. With the success rate of phase III clinical trials averaging roughly 55 percent, in-house manufacturing can be a gamble.
Furthermore, biopharmaceutical companies must also contend with the potential introduction of a competitor therapy, changes in regulatory guidelines, and shifts in geopolitics, which can all contribute to deviations from the predicted demand for a biologic. Unfortunately, due to the unique and modality-specific technologies required to produce advanced therapies, repurposing facilities to develop another therapy is not always feasible. The difficulty of repurposing plants could leave companies with an expensive and underutilized facility, one that runs the risk of being divested later down the line.
Contract developers and manufacturers: necessary and beneficial partnerships
CDMOs are a solution to these obstacles. Contract developers and manufacturers are specialized partners that ensure production capacity exists for the biopharmaceutical companies developing life-saving therapies. By focusing on high-quality and reliable manufacturing of biologics, CDMO partnerships allow the industry to pool the necessary risks of biopharmaceutical manufacturing. But CDMOs are not all created equal, and biopharmaceutical companies should carefully consider their options.
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One of the biggest benefits a CDMO partnership can offer is speed in facility construction. The best CDMOs should be able to bring construction times for building high-tech manufacturing plants down to as low as two years (compared to the five-to ten-year industry average). While two-year construction times are only found among top-tier CDMOs, having industry-leading speed available is a massive boon, improving manufacturing capacity and responsiveness. By partnering with agile CDMOs, biopharmaceutical companies can feel confident that they will always have the capacity to meet patient demand, address drug shortages, and respond to dynamic markets.
Flexibility within both the facilities and the broader organization is another defining characteristic of a high-value CDMO. As a specialized development and manufacturing partner, CDMOs adapt to changing demands in a way that in-house operations may not. The best CDMOs will design plants that allow for efficient manufacturing across a range of molecules, including complex and emerging therapies such as ADCs. Furthermore, CDMOs should be prepared to seamlessly transition between different products as market demand changes. Flexible facilities and comprehensive capabilities make for a strong partner to biopharmaceutical companies seeking efficient and adaptable development and manufacturing services.
Of course, speed and flexibility must not be achieved at the expense of quality. Meeting or exceeding regulatory standards and maintaining high-quality production across batches are foundational for every CDMO. But operational excellence will be found in companies whose dedication to quality extends beyond the facility floor. CDMOs need skilled teams capable of handling not only facility construction and validation, but also vendor management, tech transfers, strong client communication, and more. CDMO partnerships should therefore be assessed both on the output quality of their plants and their ability to deliver high-quality results across the entire company.
Expanding future capacity starts today
Investing in the development and commercial manufacturing of a new therapy will carry some degree of risk. But the right CDMO will manage the risk. As the industry continues expanding the availability and efficacy of biologic treatments, the need for strong CDMO partnerships will continue to increase. The complex chemistry and specialized technologies involved in biologics production are arguably becoming more difficult to create in-house. But it is never too late, or too early, to start engaging with a CDMO partner to enhance the speed and flexibility of your biologics development and manufacturing.
Jack ChoiJack Choi is the founder and CEO of Anatomage Inc., based in California. Anatomage is a digital healthcare platform that specializes in bringing accurate medical solutions to healthcare providers and inspiring the next generation of health professionals across the globe. Choi is also as a research scientist at the Precision Machinery Design Center in Seoul University and adjunct professor at the Industrial Engineering Department of Dongkuk University. Choi earned a B.S. in mechanical engineering from Seoul National University and an M.S. in mechanical engineering and Ph.D., Engineering from Carnegie Mellon UniversityThis post appears through the MedCity Influencers program. Anyone can publish their perspective on business and innovation in healthcare on MedCity News through MedCity Influencers. Click here to find out how.