In 2019, the global contract development and manufacturing organizations (CDMO) market was valued at about €139.9B ($151B). By 2025, it is estimated to reach a staggering €228B ($246B). The growing success of CDMOs is closely linked to major advancements in the life sciences industry.
The increasing demand for the manufacturing of highly complex biologics has driven many biotech and pharma companies to wor with CDMOs, who can support them through clinical and commercial stage manufacturing. This, in turn, means that CDMOs have to meet the growing demands or pharma sponsors.
“Today’s CDMOs must have the right approach in place to fulfill high-quality requirements, the right manufacturing technology available, and achieve regulatory compliance,” says Henrik Oberle, Vice President of the Development Service at Vetter. “Many biotech companies see CDMOs as extensions of their own service portfolio, expecting a partner with the ability to be flexible, efficient, and innovative, and provide holistic consultation that enables complex drugs to reach the market quickly and reliably.”
CDMOs can be valuable partners for biotechs, who often lack the resources, in-house know-how, or infrastructure to walk the drug development path alone. A qualified CDMO can help a biotech to understand its business priorities, develop strategies to save time and costs, and guide it through the regulatory maze.
Facing the challenges of drug development
Throughout drug development, biotechs are confronted with a number of challenges. In later stages, the fill-and-finish process for clinical development and scale-up of production is highly complex. “In these stages, there are unexpected challenges and decisions that need to be carefully and thoughtfully addressed because they can potentially impact the drug product’s success,” agrees Oberle.
Aspects, such as the compatibility of packaging materials, the development of efficient processes, meeting crucial timelines for clinical trials, and speeding up regulatory approvals, are just a few that biotechs need to fulfill.
Failure to achieve these tasks successfully can have wide-reaching consequences. “When it comes to drug development one thing is certain: there is little room for failure, and rarely a second chance,” Oberle emphasizes. “Delays, cost discrepancies, regulatory inconsistencies, and even – as a worst-case scenario – non-approval, could be the results when processes are not addressed properly.”
But as many lack the in-house expertise and necessary resources to perform these essential drug development and manufacturing tasks alone, they outsource them to CDMO partners once they have successfully developed their drug substance.
“Simply put, partnering with a CDMO allows a greater focus on core competencies,” Oberle adds. “With the patients in mind who must later rely on the drugs that are being manufactured to help them manage their disease, a comprehensive and well-planned approach is beneficial for the overall development and subsequent market success.”
What key characteristics should a CDMO bring to the table?
Due to the complexity and costliness of drug manufacturing and regulatory processes, biotechs need to find a partner who can handle these tasks. One wrong choice in partnering, and the drug development project can lose time and cost money.
“A partner that is strategic in its approach to product manufacturing can greatly influence key factors such as timelines, quality, and costs,” Oberle explains. “When selecting a partner to support drug product manufacturing, we therefore see four core pillars critical to the selection process: level of experience, cultural fit, corporate stability, and long-term resources.”
Under the umbrella of these four pillars is the ability to handle the drug substance safely, a high-quality audit system, the know-how, and equipment to perform the necessary analytical tests, and having the biotech’s packaging configuration or the ability to source it in a timely manner, says Oberle. Moreover, CDMOs should have good project management capabilities, supportive customer service, and be responsive and communicative.
“The process of clinical development and manufacturing is a complex one and depends on a variety of factors,” Oberle adds. “The process diversity of individual drug substances has increased and, in turn, has affected all parties involved in the handling and processing of these substances.”
“A well-thought-out preparation and an early, carefully planned drug development process can have a significant influence on the overall success. The result of what will come out at the end of a process will likely depend on the quality and thoroughness of what was put in.”
Working with experts from early-stage development through commercialization
Based in Ravensburg, Germany, Vetter has more than 35 years of experience in biologics manufacturing. As a global CDMO, the company has production facilities in both Germany and North America and supports large as well as small biotech and pharma companies in the development of injectables. Vetter has services ranging from early-stage development support with clinical manufacturing to commercial production and packaging solutions.
“We specialize in the aseptic manufacturing of prefilled injections systems and have experience with a variety of complex compounds,” says Oberle. “Our development service partners with clients from preclinical development through phase III to market launch. We plan for commercial production from a product’s earliest stages.”
“Our services include packaging and process design, feasibility and stability studies, technical and engineering batches, GMP clinical manufacturing, and analytical and regulatory support. We develop processes that mirror those at our commercial production facilities, enabling product transfer to our commercial manufacturing.”
The future role of CDMOs
In the future, Oberle believes that the relationship between sponsors and their CDMO partners will further intensify. The complexity of CDMOs’ work will increase with new markets, demographic changes, and new demands in the clinical production of pharmaceuticals. Here, being flexible and adapting portfolios to match innovative approaches can help CDMOs to their success, says Oberle.
With the appearance of new trends, drug development processes will also change. “No doubt, digital innovations will become key in the development of application systems as well as in production and supply planning processes,” Oberle adds. “Pharma 4.0, which refers to the linking of the industrial production area with modern information and communication technology, will also have a strong effect on the cooperation of CDMOs with their customers.”
Another trend we see is towards highly specialized medications, resulting in reduced batch production, with the need for innovative and flexible manufacturing technologies to further optimize effective production.”
Images via Shutterstock.com