In the biopharma manufacturing industry’s race for expansion, few companies are as equipped for the sprint like Samsung Biologics.
Since it was established in 2011 and in short order became a CDMO force, Samsung has sought to do everything quickly. A conversation with CEO John Rim has a consistent theme—speed.
“We scale up very quickly. Speed, in terms of our expertise, in terms of delivering quality to our clients and regulatory authority, it’s second to none,” Rim said in a recent interview. “When companies are taking four years, five years to build facilities, we can do that in two-and-a-half, three years.”
That capability serves Samsung particularly well these days as companies in the industry are focused more than ever on building capacity and doing it post-haste to address the urgent need for CDMO services.
Two years ago, demand for contract manufacturing was already outstripping supply. Then the pandemic exacerbated the shortfall as many companies put their scheduled projects on hold to develop and produce vaccines, antibodies and other treatments to combat the virus. Samsung has been among them, manufacturing shots for Moderna and monoclonal antibodies for Vir/GlaxoSmithKline and Eli Lilly.
Growth is a Numbers Game
Samsung is ready, willing and—most of all—financially able to answer the increasing demand, Rim says. In August, the deep-pocketed conglomerate revealed that it had earmarked 240 trillion won ($205 billion) through 2023 to bolster its biopharmaceutical, semiconductor and telecommunications businesses.
For Samsung Bio, the investment will fund two new manufacturing facilities, Plants 5 and 6, on grounds adjacent to its current campus in Incheon. This comes on top of the ongoing construction of Plant 4, dubbed “Super Plant” because of its $2 billion price tag and size, which will equal that of Plants 1, 2 and 3 combined.
No project is a better example of Samsung’s ability to scale up quickly as the Super Plant. Construction began last October and at the time the facility was set to be complete by the end of 2023. Now Samsung says it could be ready by the middle of 2023, with phase one coming online in the fourth quarter of 2022.
“Only two years between groundbreaking and GMP ready,” Rim says with pride.
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Completion of the Super Plant will add 256,000 liters of capacity, bringing total site capacity to 620,000 liters, the most at a single complex in the world, Samsung says. And for Samsung, the Super Plant can’t come soon enough as the company has booked more projects through 2023 than Plants 1, 2 and 3 can handle.
Samsung Bio’s Expansion Formula
Rim breaks the company’s expansion into three general categories. One is focused on building additional capacity for drug substance manufacturing, fill-finish services and Samsung’s clinical development arm.
Another component centers on adding platforms to produce monoclonal antibodies and mRNA products, plus cell and gene therapies. For example, by early next year, Samsung will be able to manufacture mRNA vaccine substance for Moderna in addition to the fill-finish services that it already provides.
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Lastly, Samsung Bio aims to grow beyond Korea’s borders so it can better serve its global customer base. The company is eyeing opportunities—both greenfield and M&A—in the United States and Europe, Rim says. China is a target as well but with less immediacy.
“It’s more when not if,” Rim said. “We’re continuing to look at when is the opportune time to make an investment in the United States and make an investment in Europe as well.”
Pandemic Lessons Learned
Samsung has fared well during the pandemic, with minimal disruptions to its around-the-clock operations, Rim said. A big focus during the pandemic has been transparency. To that end, Samsung Bio provided clients and regulators virtual access to its facilities.
“Regulatory authorities can access the facilities, the documents,” Rim said. “We put that in place—a live virtual tour audit capability.”
In many ways, pandemic lessons have changed how Samsung Bio thinks about the future. One example is mRNA technology, which Rim believes is a game-changer and could change the industry the same way monoclonal antibodies did decades ago.
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“We’re just seeing the tip of the iceberg,” Rim said. “I do think they will continue to expand in that technology. And I think we have a key role to play as well in terms of our (drug substance) production capabilities in mRNA.”
For Samsung Bio, another major takeaway from the pandemic is the importance of supply chain flexibility. Dual and multiple sourcing of raw materials will be key to ensuring supply continuity, the exec says.
And then, of course, is Samsung Bio’s need for speed.
“We need to provide fast, agile service to our clients so they can be fast to market,” Rim said. “We’ve actually reduced the speed to market for tech transfers for our clients quite rapidly. Historically, I think it was 6 to 9 months, now it’s 3 to 4 months.”