Developing and manufacturing a new drug is a long and very costly process. Biotechnology and pharmaceutical companies must go through numerous phases, adhering strictly to regulatory requirements. Outsourcing tasks to external partners is a common practice to bridge gaps in resources and proceed more efficiently through the various stages. Contract Manufacturing Organizations (CMOs) perform manufacturing tasks on behalf of their clients. What do CMOs do, and why is it beneficial to work with them? Our blog post delves into this question.
Let's explore what tasks CMOs perform and what other outsourcing options exist!
What does a contract manufacturing organization (CMO) do?
A Contract Manufacturing Organization produces products on behalf of its clients under industrial conditions. Their tasks include everything from initial manufacturing steps to final stages, such as packaging, labeling, and wholesale or direct consumer distribution.
These factories are equipped with excellent facilities, modern machinery, and skilled personnel, allowing them to meet their clients' expectations and comply with regulatory standards. According to Fortune Business Insights, the global market for CMOs was worth $92.4 billion in 2018, and estimates suggest it could double to $188 billion by 2026.
Clients have several options if they wish to outsource different phases of work. Manufacturing outsourcing is one option, but the development phase or the entire process, including both development and manufacturing, can also be outsourced. We will present these options in the following sections!
What is a CRO and a CDMO?
A CRO (Contract Research Organization) provides research and development services to pharmaceutical and biotechnology companies. These services include designing, conducting, and analyzing clinical trials. CROs enable pharmaceutical companies to bring new products to market more efficiently and quickly. Since clinical research is extremely costly and time-consuming, CROs offer significant advantages by reducing development time and costs through their expertise and resources.
CROs engage in various clinical trial phases, including initial safety tests and large-scale efficacy studies. Their services also encompass data management, regulatory consulting, and reporting. Collaborating with a CRO allows pharmaceutical companies to work with an external, independent team of experts, relying on the latest scientific and technological advancements.
A CDMO (Contract Development and Manufacturing Organization) provides both development and manufacturing services to pharmaceutical companies on a contractual basis. CDMOs play a crucial role in accelerating the market entry of new drugs and therapies. They offer extensive expertise from the initial development phases to final manufacturing, enabling pharmaceutical companies to develop their products more efficiently and cost-effectively.
The advantage of CDMOs is that they provide the entire development and manufacturing process in one place. This includes research and development activities, conducting clinical trials, manufacturing and packaging that comply with regulatory requirements. Working with such organizations allows pharmaceutical companies to rely on an external expert team using the latest technologies and methods instead of their own resources.
The flexibility and expertise offered by CDMOs provide significant competitive advantages for pharmaceutical companies. By optimizing development and manufacturing processes, CDMOs contribute to faster market entry and reduced development costs, thereby promoting innovation and improving patient care.
Why collaborate with a contract manufacturing organization?
CMOs offer numerous benefits to pharmaceutical companies. Firstly, they enable significant cost savings. By outsourcing manufacturing processes, companies do not need to invest in their own manufacturing capacity and infrastructure. This is particularly beneficial for smaller companies that lack the necessary resources to handle large-scale production.
CMOs also provide flexibility. Since these organizations manufacture for multiple clients, they can quickly adapt to changing market demands. This allows companies to easily increase or decrease production volumes without committing to long-term investments.
Expertise and experience are also crucial advantages. CMOs often possess specialized knowledge and technology that pharmaceutical companies may not have. This can improve product quality and manufacturing efficiency. Additionally, ensuring regulatory compliance becomes easier since CMOs stay up-to-date with the latest industry standards and regulations.
Collaborating with a CMO allows pharmaceutical companies to focus on innovation and research and development while entrusting manufacturing tasks to a reliable partner.
Inthera is a leading provider of pharmaceutical services, distinct from CMOs, CROs, and CDMOs. We specialize in clinical trial supply, medicine shortage supply, pharmaceutical regulatory affairs, and EU GMP services. Our extensive and reliable partnerships allow us to offer competitive prices.
Contact us to navigate the pharmaceutical industry with confidence. Discover how we can support your needs!