CDMO Samsung Biologics’ Plant 4 and the Future of Biopharmaceutical Manufacturing 

The market for contract development and manufacturing organizations (CDMOs) has taken off in recent years as pharmaceutical companies have realized the value in working with manufacturing partners to produce a variety of biopharmaceuticals. Experts predict that this growth will continue, with the CDMO market reaching $157.7 billion by 2025 at a compound annual growth rate of 6.9%, a higher CAGR than that of the broader pharmaceutical industry. 

Samsung Biologics, one of the world’s largest CDMOs, has been a key player in this growth. With the commencement of operations at its largest plant yet, the company is looking to continue to drive expansion in biopharmaceutical manufacturing.

The plant, Samsung Biologics’ fourth at its South Korea headquarters, began partial operations in October and is expected to be fully operational in 2023. Plant 4’s full capacity will be 240,000 liters, the most at any single facility in the world. This will bring Samsung Biologics’ industry-leading capacity to 604,000 liters as it continues to pursue CEO John Rim’s plan for “multidimensional growth,” accounting for approximately a quarter of the world’s biopharmaceutical manufacturing capacity.

“At the P4 groundbreaking ceremony in late 2020, we committed to have the plant up and running by October this year,” said Rim in a press release announcing the launch of partial operations. “I am very proud to have delivered on that promise and confident that this will further solidify our position as a global leading CDMO. As a trusted partner, we will continue investing domestically and globally to support our clients worldwide and provide expanded services.”

New Avenues for CDMO Industry Growth

While the CDMO industry was growing prior to the onset of the COVID-19 pandemic, supply chain issues and the demonstration of innovative biologics use cases during the pandemic have accelerated the industry’s growth.

Supply shortages led many pharmaceutical companies to recognize the value of having a manufacturing partner with additional capabilities and supplies. And as the world sought a COVID-19 vaccine that could be produced at a massive scale, biopharmaceutical manufacturing was at the center of global attention.

Ultimately, mRNA vaccine production was the solution to combating COVID-19, with the first mRNA vaccines approved for human use successfully developed and manufactured at an unprecedented pace. The CDMO industry, including Samsung Biologics, had a role to play in this process. Moderna partnered with Samsung Biologics to produce its COVID-19 mRNA vaccines, with the CDMO providing fill/finish services at its facilities at Songdo, South Korea.

The demonstration of effective mRNA vaccine production at such a large scale should spur more development of this innovative technology, which has a wide variety of potential applications outside of COVID-19 prevention. Researchers are working on mRNA therapeutics to treat diseases ranging from HIV to cancer and heart disease.

Samsung Biologics aims to be a leading CDMO for mRNA development and manufacturing as these therapeutics are developed. Following its drug product partnership with Moderna, Samsung Biologics decided to expand its mRNA capabilities, building an end-to-end mRNA suite that can both produce the active drug substance in an mRNA vaccine and provide the drug product services to transfer this substance into the vaccine that ultimately reaches patients.

The suite completed its first project in the summer of 2022, producing a COVID-19 vaccine candidate at commercial-scale for GreenLight Biosciences in just seven months.

“This demonstrates a major achievement in our continuing goal to offer one-stop, end-to-end mRNA production from drug substance to aseptic fill/finish to commercial release, all from a single site, as we strive across our biomanufacturing network to fight the pandemic,” said Rim in a statement on the completion of the project’s first run.

In addition to mRNA, other potential new avenues for growth that Samsung Biologics is pursuing include biosimilars, which are in some ways a biopharmaceutical analog to generic pharmaceuticals, and bispecific antibodies, which target multiple antigens as opposed to the single antigen capabilities of monoclonal antibodies.

Experts at Samsung Biologics believe that the experience of navigating the pandemic will continue to have a downstream impact on its growth in new avenues, as developing these capabilities requires agility and efficiency.

Plant 4 and Expanded Manufacturing Capacity

In addition to exploring these new avenues of growth within the CDMO industry, Samsung Biologics is continuing to build on its status as an established provider of monoclonal antibodies.

Plant 4 will be a key contributor to this effort. Samsung Biologics has already secured contracts for projects at the plant, which is providing approximately 60,000 liters of capacity just 23 months after Samsung Biologics began construction. The company will look to significantly expand production in 2023 as the plant will be fully operational with  240,000 liter capacity.

This capacity will build on that of Samsung Biologics’ other three plants. These facilities, constructed within the first seven years of the CDMO’s establishment in 2011, provide 30,000 liters, 154,000 liters, and 180,000 liters of capacity.

Samsung Biologics doesn’t plan to stop expanding anytime soon. It recently announced the acquisition of 357,366 square meters (about 88.3 acres) of land in the Incheon Free Economic Zone. This land, which is 30% larger than the location of its current Bio Campus, will provide space for the construction of a second Bio Campus. The CDMO plans for the new campus to provide both additional manufacturing capacity and an Open Innovation Center.

“Operational excellence has been crucial to our strong performance; we do an outstanding job for our customers and, for example, are able to build facilities faster than any other player in the industry,” said Rim in a recent interview. “Additionally, Samsung Biologics has a phenomenal ability to rapidly carry out technology transfers; our average time frame is three to four months, compared to an industry standard of six to eight.

“All of this has led to year-on-year sales growth of 35% over the last few years with operating income margins in the 30th percentile.”

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