Contract development and manufacturing organizations have emerged as essential partners for pharmaceutical companies seeking to accelerate drug development and ensure efficient manufacturing processes. Acting as behind-the-scenes collaborators, CDMOs have played a pivotal role in transforming the industry over the past two decades.
As John Rim, the CEO of Samsung Biologics, explained in a recent interview, more and more pharmaceutical companies are partnering with CDMOs as a means of directing resources and time to research and development rather than manufacturing.
“Over the last couple of years, many biopharma companies have been showing a growing interest in contract manufacturing to mitigate supply chain risks and focus on streamlined [research and development],” he said.
“We are seeing a very positive momentum as the marketplace continues to grow, with mAb [monoclonal antibody] therapies having a double-digit growth thanks to tech advancements and wealth increases across the globe,” Rim continued. “From this perspective, the drugs that are more interventional and that help patients live longer are going to take off spectacularly in the following years. The biologics market will probably topple the small molecules one, but the whole evolution is closely linked to the popularization of new technologies.”
What Is a CDMO?
CDMOs partner with pharmaceutical and biotechnology companies that require specialized expertise and infrastructure to expedite their drug development programs. These collaborations often involve the transfer of manufacturing processes and technical know-how to CDMOs, allowing the pharmaceutical companies to focus on research, marketing, and regulatory activities. These strategic partnerships enable the efficient allocation of resources, reduction in time to market, and increased flexibility in adapting to market demands.
To better understand the role of CDMOs, it’s important to distinguish between contract development organizations and contract manufacturing organizations. CDOs primarily focus on the early stages of drug development, providing services such as formulation development, process optimization, and analytical method development. Their expertise lies in transforming a drug candidate into a viable pharmaceutical product ready for clinical trials.
On the other hand, CMOs specialize in large-scale manufacturing and supply chain management. They possess state-of-the-art facilities that adhere to strict regulatory standards to produce pharmaceutical products in commercial quantities. CMOs ensure the efficient and cost-effective production of drugs, allowing pharmaceutical companies to meet market demand and maintain a steady supply of medications.
A CDMO combines these services, offering a range of both development and manufacturing options for clients. Rim’s explanation of Samsung Biologics’ range of services is illustrative of the variety of roles a CDMO can play.
“We currently have four plants with a capacity of over 600,000 liters. This amounts to around 25% to 30% of the total global contract manufacturing capacity. With this capacity, we develop drugs for our clients across major diseases like cancer, immunology, and COVID-19,” he explained. “We employ three major CDO technology platforms to offer. S-CHOice allows us to produce high cell line yields, S-DUAL is a bispecific platform and DEVELOPICK enables us to identify the most efficient cell line.”
An Industry Shift
Over roughly the past two decades, CDMOs have brought a paradigm shift to the biopharmaceutical industry. Their expertise, infrastructure, and efficient operations have contributed significantly to advancements in drug development and manufacturing.
CDMOs provide pharmaceutical companies with access to specialized knowledge, cutting-edge technologies, and optimized processes. By outsourcing development activities to these companies, drug discovery and formulation time lines are often significantly reduced, enabling faster delivery of potentially lifesaving therapies to patients. For example, CDMOs played a key role in meeting global demand for vaccines and other medicines during the COVID-19 pandemic.
“Historically, CDMOs would transfer products in around six months, but we have been able to half that time, particularly during the pandemic when monoclonal antibody therapies were direly sought-after,” said Rim. “Besides these, we helped Moderna with packing their vaccine into vials and getting it approved in a five months time frame.”
The scale and complexity of manufacturing biopharmaceuticals, such as mAbs and mRNA vaccines, require sophisticated infrastructure and expertise. CDMOs have invested heavily in advanced manufacturing facilities and process technologies to meet these demands. After the success of mRNA vaccines to combat the pandemic, Samsung Biologics decided to install an end-to-end mRNA vaccine production suite at its headquarters in Songdo, South Korea. And with when its fourth plant becomes fully operational this year, it now will provides over 600,000 liters of biomanufacturing capacity.
Developing and maintaining this level of in-house manufacturing capabilities would be financially burdensome for pharmaceutical companies, particularly during uncertain market conditions. By partnering with CDMOs, companies can shift the capital expenditures and operational risks associated with manufacturing to specialized organizations, allowing them to focus on core competencies while trusting the CDMO’s manufacturing expertise.
The rapid growth of a company like Samsung Biologics is a solid indicator of this industry shift, and as Rim explained, the trend seems likely to continue.
“[in 2011] after careful business planning, it was determined that contract manufacturing and contract development were the ideal areas to leverage Samsung’s technology skills acquired after 80 years of existence. We started out as a fairly small venture, with about 50 people; today we are close to 5,500 experts.”