South Korean contract development and manufacturing organisation (CDMO) Samsung Biologics has been on a steep upward growth trajectory since receiving its first licence to produce biologic drug substances in 2015.
That FDA approval was followed in 2016 by a Certificate of Good Manufacturing Practice (GMP) compliance from the EMA for biologics drug substance and drug product, and the company now has over 450 approvals from regulators around the world. The expansion of Samsung’s manufacturing licences is mirrored in the growth of its performance, which saw it achieve revenues of $3.1bn (Won4,557bn) in 2025, a 30% increase from the previous year.
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Until now, that work has been centred on the Songdo Bio Cluster in the South Korean city of Incheon, where Samsung will have three campuses, having recently acquired land for Bio Campus III, which will be set aside for future modalities including work on cell and gene therapies and vaccines. The cluster will also be the location for Samsung’s forthcoming open innovation centre, which is due to open in 2027 and is being built in partnership with Lilly Gateway Labs. But a key part of the company’s plans for continued growth involves adding capacity outside its home country.
On 20 July 2026, Samsung unveiled its plans for the $1.8bn (SFr1.46bn) acquisition of PolyPeptide Group, which specialises in peptide-based active pharmaceutical ingredients (APIs) and produces one third of the commercially approved peptides in the world. In addition to expanding Samsung’s capabilities beyond antibodies and ADCs and into peptide therapeutics, including GLP-1s, its deal with the Swiss CDMO also comes with a network of sites across Sweden, Belgium, France, the US, and India, together with a corporate office in Switzerland and an innovation centre in Strasbourg, France.
The PolyPeptide deal is expected to close before the end of 2026, when it will build on Samsung’s first major M&A transaction of the year. That saw the South Korean CDMO complete its $280M acquisition of GSK’s Rockville, MD, US facility on March 31, 2026. The agreement gave Samsung its first US manufacturing presence and an additional 60,000L of drug substance capacity, increasing its global capacity to 845,000L.
Samsung Biologic’s growth strategy
Speaking to Pharmaceutical Technology at the 2026 BIO International Convention (BIO 2026) in San Diego, California, in June 2026, James Choi, executive vice president, chief marketing officer and head of sales support, project management, and global public affairs, discussed Samsung’s growth strategy, the need for a diverse supply chain, and how the new Maryland facility fits into those plans.
“Geographically, we’ve always been looking at expanding, starting with the US, because about half of our clients are US-based,” he explained, noting that the search for the right site was not a short-term reaction to the US political pressure on the pharma industry to onshore its manufacturing that grew throughout 2025 and into 2026.
“[It began] many, many years before that and we looked at other plants, existing plants, we looked at greenfield opportunities, different locations, different biotech corridors, where we could build out and scale out and, for one reason or another not everything checked off, but this location came up and it addressed all of our needs.
“Number one, it was in an existing kind of biotech hub, where we have access to talent, and in an area that has a strong technology/biotechnology ecosystem, and we also acquired it from one of our clients, GSK, so the talent there, roughly about 500 people, are well seasoned, and they have all the know-how and expertise in bio manufacturing, specifically the type of mAbs [monoclonal antibodies] that we create.”
The relationship with GSK forms a key part of the deal, which will see the UK pharma company continue to benefit from the site as Samsung supplies it with the products previously manufactured there. But, in a sign of GSK’s reduced needs from the facility, Samsung will also transition to serve additional contract manufacturing needs.
Expansion at Rockville, Maryland
Samsung’s new US site at Rockville, Maryland, can already support clinical and commercial biologics production across multiple manufacturing scales from its two cGMP manufacturing plants. Plans to expand the facility are expected to involve the addition of further capabilities and the strengthening of its long-term operations.
The company wants to ensure that services can be offered in a seamless manner across its different campuses and will apply an approach for plant-to-plant processes and equipment equivalency that it terms ‘ExellenS’; this approach aims to expedite regulatory approvals and speed up tech transfers. Alongside this, Samsung is conducting a study to assess how it can best expand the site.
“We do know that the site has potential to add more bioreactors,” Choi explained. “We’re looking at the different configurations, additional equipment that we would add or, in some cases, maybe even replace to allow the site to be more up to date, and also that equivalency with our existing campus in South Korea, so that it’s seamless in terms of process transfers and stuff like that.”
Manufacturing and supply chain diversity
Samsung’s acquisition of the former GSK site in Maryland provided its first facility in the US but it will be quickly followed further geographic diversification across the US, Europe, and India once the PolyPeptide deal goes through. After all, the US is not the only region looking to shore up domestic biopharma manufacturing, with the EU’s Critical Medicines Act – finalised in January 2026 – also aimed at boosting the region’s production of APIs and essential drugs.
“There’s always going to be a balance” when it comes to where production takes place, Choi said. “Nobody fully puts all their eggs in one basket. You’re always going to want to diversify your supply chain to reduce risk, so clients will always have a need for a secondary supply for that diversification of the risk portfolio, especially for their flagship products.”
“Time and time again, geographic diversification has proven to be a sound business decision,” he concluded.
