The Role of CDMOs
Outsourcing services have rapidly grown in popularity among the pharmaceutical industry, which has largely been driven by the growth of small molecules, diversity of drug classes, and the need to optimize research, development, and manufacturing costs.
Contract development and manufacturing organizations (CDMOs) offer drug development and drug manufacturing services and expertise to pharmaceutical and biopharmaceutical companies on a contract basis, enabling pharmaceutical companies to outsource various business needs. On average, it takes at least ten years and $2.6 billion for a novel therapeutic to transition from initial discovery to market, making it a common goal for pharmaceutical companies to de-risk R&D efforts, accelerate the time to market of their pipeline drugs, and simultaneously reduce development and manufacturing costs.
Time is a crucial asset for (bio)pharmaceutical companies, and utilizing CDMOs can free-up more time and internal resources to be allocated to innovation, drug discovery, and business development. CDMOs also eliminate the need for pharmaceutical companies to harbor robust in-house development and manufacturing experts.
CDMO vs. CMO
The primary difference between CDMOs and contract manufacturing organizations (CMOs) are development service offerings, which can cultivate long-term strategic partnerships. In 2014 many biopharma companies’ increased the use of CMOs for development activities leading to more companies adopting the CDMO acronym to be more attractive to pharmaceutical sponsors and have a competitive advantage over traditional CMOs that primarily focused on large-scale manufacturing projects.
Outsourced development assistance allows pharmaceutical companies to leverage development expertise they likely lack in-house, and finding this service within the same organization fulfilling manufacturing requirements saves time and creates a strong partnership where the CDMO can fully comprehend and address the client’s needs. Increased therapeutic pipelines, novel classes of drugs, and drugs increasing in complexity supports the idea that outsourcers are shifting away from traditional usage of CMOs for capacity needs alone to also needing development expertise.
The US FDA approved 48 New Molecular Entities in 2019, reflecting a robust clinical development pipeline and massive development and manufacturing needs. External collaborations with CDMOs reduce production bottlenecks by providing the necessary bandwidth and expertise and eliminate costs for in-house development. With novel drug classes arising and development needs becoming more demanding, CDMOs must be agile, flexible, multidisciplinary, and innovative to accelerate successful product launch and boost drug development and manufacturing efficiency.
The CDMO market is highly competitive requiring companies to differentiate themselves to appeal to their target pharmaceutical partners, while updating and expanding technical capabilities to advance with therapeutic innovations. Modern CDMOs create a collaborative environment to streamline communication between teams; have strong project management teams with an ability to coordinate multiple projects with diverse requirements; and provide comprehensive services, from drug development through manufacturing commercial supply. Many now market themselves as “one-stop shops” where, they offer services spanning process development, cGMP (and non-cGMP) manufacturing, analytics, and quality and regulatory compliance, and some also offer active pharmaceutical ingredients (APIs) and formulations services. These wide-ranging capabilities require multidisciplinary experts and enable high agility so CDMOs can address client’s specific and evolving needs.
With CDMOs and pharmaceutical companies developing long-term partnerships, CDMO capabilities are being expanded and integrated into existing operations generating a greater reliance on outsourcing partners and identifying experts at specific stages of drug development. CDMOs are adapting to this demand by specializing in wide-ranging services to provide solutions tailored to specific client needs and efficiently transition from the preclinical phase to full-scale commercial launch.
Each new project has differing requirements, requiring CDMOs to quickly adapt by either providing a “one-stop shop” of services, offering capabilities that meet a client’s particular requirements, or investing in new technological assets. Having a range of capacity capabilities also enables CDMOs to execute both small and large-scale projects, which is especially important when servicing clients with large product pipelines and creating a diverse client portfolio.
Modern CDMOs are prioritizing technological innovation, such as automation and synthetic biology, to address new client needs, increase development and manufacturing efficiency, and optimize process parameters. CDMOs that have avoided massive expenditures on traditional equipment have an advantage of greater flexibility in technological assets they can acquire. CDMOs with this flexibility can address client needs by promptly investing and implementing new technology, which can then be used for subsequent projects to either create long-term partnerships and attract new clients developing similar drugs.
As the CDMO market continues to grow and clinical pipelines diversify and expand, outsourced developers and manufacturers will need to adapt by developing highly collaborative partnerships, becoming flexible in their capabilities, and investing in innovative technologies that can enhance efficiency.
5 Examples of Modern CDMOs
Avid Bioservices is a commercial biologics CDMO that develops and manufactures biopharmaceuticals derived from mammalian cell culture. This organization offers full lifecycle capabilities including process development, cGMP manufacturing, analytical services, and quality and regulatory compliance.
Thermo Fisher Scientific’s Pantheon develops and manufactures small molecules and large molecules, including biologics. In addition to these services, it offers expertise in developing oral solid dosage technologies, steriles, and softgels. Because it is backed by a life sciences giant, it has extensive resources and expertise that enables new market penetration, technological innovation, and geographic reach.
Cambrex Corporation prides itself on being the expert in small molecule development and manufacturing. Cambrex offers drug substance, drug product, analytical services, and quality and regulatory services across all stages of drug development and manufacturing. This organization is flexible in manufacturing capacity reflected by its recent investment in a new facility located in Karlskoga, Sweden.
Samsung Biologics is a one-stop-shop CDMO and CRO (contract research organization) with a focus on biopharmaceuticals. This organization has been recognized for excellent quality, capability, and reliability and has demonstrated its dedication to technology innovation and transparent project management by investing in new manufacturing technologies and recently launching a virtual client-facing platform.
AMRI Global offers CDMO and CRO services spanning drug discovery, drug development, API development, analytics, manufacturing, and product development with extensive experience in biologics and synthetic compounds. AMRI is dedicated to developing and adopting innovative development and manufacturing technologies, such as the T3P®, to boost efficiency and quality.
Outsourcing development and manufacturing is a critical source of drug substance and drug product delivery, which pharmaceutical companies heavily rely on to increase pipeline drug speed to market. Many service providers now offer a full suite of solutions with the ability to research, develop, and manufacture multiple types of therapeutics, enabling long-term partnerships with clients, as well as a portfolio of clients with diverse needs. Not only do modern CDMOs have extensive technical capabilities, but also often offer expertise in full lifecycle drug development, quality and regulatory compliance, and technology commercialization. As the pharmaceutical industry transitions to personalized medicines and new drug classes emerge, contract service providers will need to innovate and adapt; Some CDMOs have an advantage as they already have the capabilities and cutting-edge technologies to rapidly pivot in this changing industry.