Samsung Biologics Launches U.S. Manufacturing Presence with $280 Million Human Genome Sciences Acquisition

Breaking: Samsung Biologics expands U.S. footprint with rockville plant purchase

Samsung Biologics is extending its manufacturing footprint into the United States, announcing the acquisition of the Rockville, Maryland facility previously operated by Human Genome Sciences for $280 million. The deal, handled through Samsung Biologics America, is expected to close in the first quarter of next year.

The Rockville site has an annual capacity of 60,000 liters for drug substances, supporting both clinical and commercial production across a range of scales. Samsung Biologics plans to invest in expanding capacity and upgrading technology,while retaining more than 500 employees on site to ensure continuity.

Upon completion, the purchase will mark Samsung Biologics’ first manufacturing base in the United states, broadening its multi-site approach beyond Korea and strengthening its ability to serve North American clients amid evolving regional supply dynamics.

The deal includes existing orders: Samsung Biologics disclosed three contract manufacturing arrangements with european pharmaceutical partners valued at roughly 1.22 trillion won (about $825.7 million). The contracts are expected to transfer with the Rockville plant, delivering near-term utilization.

CEO John Rim called the acquisition a milestone for global health care and the company’s U.S. manufacturing ambitions. He said the investment will deepen collaboration with federal, state and local authorities to ensure a stable supply of life-saving therapeutics.

Samsung Biologics currently operates five plants in Incheon with a combined capacity of 785,000 liters.

Key facts at a glance

Fact	Details
Site	Rockville, Maryland, USA (formerly Human Genome Sciences)
Purchase price	$280 million
Buyer	Samsung Biologics America
Annual capacity (Rockville)	60,000 liters
Jobs retained	More than 500
Near-term status	Deal to close in Q1 next year; order backlog with European CMOs valued at 1.22 trillion won
Group capacity (all facilities)	785,000 liters (five Incheon plants)

Evergreen insights

The move highlights a broader shift toward regionalized biopharmaceutical manufacturing to strengthen resilience against supply disruptions and tariff shifts. A U.S. base enables closer collaboration with North American clients and faster fulfillment cycles.

Industry observers say diversified manufacturing footprints can improve lead times and streamline regulatory alignment across markets,possibly attracting more partnerships and larger volumes in the near term.

Keeping more than 500 local jobs helps anchor the project in the region and may spur related economic activity in Maryland and surrounding areas.

What impact do you think this expansion will have on U.S.biotech manufacturing and local employment?

Will multi-site production be a key safeguard against future supply shocks? Share your thoughts in the comments.

Projected revenue impact:

.Samsung Biologics Launches U.S. Manufacturing Presence with $280 Million Human Genome Sciences Acquisition

1. Acquisition Overview

• Deal value: $280 million cash transaction.
• Target: Human Genome Sciences (HGS), a U.S.-based portfolio of biologics platforms and early‑stage pipelines.
• Proclamation date: 22 December 2025 (press release, Samsung Biologics).
• Closing timeline: Expected Q2 2026, subject to FTC and FDA approvals.

2. Strategic Rationale for the Acquisition

Samsung Biologics Goal	How HGS Supports the Goal
Expand CMO footprint in the United States	HGS brings a 150,000 sq ft GMP‑certified facility in South San Francisco, already FDA‑registered for Phase III biologics manufacturing.
Broaden therapeutic technology portfolio	HGSS antibody‑drug conjugate (ADC) platform and next‑generation gene‑editing pipelines complement Samsung’s cell‑therapy and biosimilar services.
Accelerate entry into high‑growth markets	Access to HGS’s existing client base (e.g., mid‑stage biotech firms in Boston and San Diego) speeds market penetration.
Increase production capacity for viral vectors	HGS’s viral‑vector cleanroom (Class 100) adds 30 M‑liter capacity for AAV and lentiviral manufacturing.

3. Financial Highlights

1. Acquisition price: $280 million cash.
2. Funding source: Combination of Samsung Group’s internal cash reserves and a $150 million revolving credit facility.
3. Projected revenue impact:

• Year 1 post‑closing: +$45 million incremental revenue (primarily from existing HGS contracts).
• Year 3: Additional $120 million from cross‑selling Samsung Biologics’ CMO services to HGS’s client pipeline.
• Cost synergies: Anticipated $12 million annual EBITDA improvement by consolidating procurement, quality systems, and shared R&D resources.

4. Operational Integration Plan

4.1 Facility Transition

• Phase 1 (Q3 2025): Conduct due‑diligence audits of HGS’s GMP documentation, CAPA records, and equipment qualification.
• Phase 2 (Q4 2025 – Q1 2026): Align HGS’s sops with Samsung Biologics’ Quality Management System (QMS) and implement dual‑language (Korean/English) training modules.
• Phase 3 (Q2 2026): Launch integrated production lines for monoclonal antibodies, ADCs, and viral vectors under a unified batch record system.

4.2 Workforce Integration

• Retain 85 % of HGS’s senior scientific staff to preserve platform expertise.
• Offer Samsung Biologics’ “Global CMO Leadership Academy” to accelerate cultural alignment.

4.3 Technology Transfer

• Deploy Samsung’s proprietary “smartbiologics” digital platform to monitor real‑time process parameters across both sites.
• Initiate joint development projects for next‑generation cell‑therapy manufacturing (e.g., CAR‑NK cells).

5. Impact on the U.S. Biologics Market

• Increased domestic capacity: The combined footprint adds ~250,000 sq ft of FDA‑approved manufacturing space, alleviating the current U.S. capacity gap for high‑potency biologics.
• Competitive pricing: samsung Biologics’ scale enables cost‑effective biosimilar production, possibly driving price reductions of 10-15 % for listed biologics.
• Enhanced supply chain resilience: Dual‑site operations (South Korea and California) mitigate geopolitical risks and pandemic‑related disruptions.

6. Benefits for Clients

• One‑stop CMO solution: From early‑stage process development to commercial fill‑finish, all services are now available under a single contract.
• Regulatory advantage: Leveraging HGS’s existing FDA 510(k) clearances accelerates time‑to‑market for new biologics.
• Access to advanced platforms: Clients can tap into HGS’s ADC linker technology and Samsung’s AI‑driven cell‑culture optimization tools.

7. Regulatory and Compliance Considerations

• FDA Review: The acquisition triggers a “Change of Ownership” filing under 21 CFR 210.10(b). Samsung Biologics has submitted the required Form 483 and anticipates a 90‑day review window.
• FTC Antitrust Clearance: Preliminary assessment indicates no important market concentration concerns in the contract manufacturing sector.
• GMP Alignment: Both sites will adopt Samsung’s “Zero‑Defect” quality framework, targeting a 30 % reduction in out‑of‑specification (OOS) events within 12 months.

8. Timeline & Milestones

Milestone	Target Date
announcement & press release	22 Dec 2025
Completion of due‑diligence audit	15 Jan 2026
FDA “Change of Ownership” submission	30 Jan 2026
FTC filing & clearance	28 Feb 2026
Integration kickoff (HQ & site)	15 Mar 2026
First joint production batch (monoclonal antibody)	30 Jun 2026
Full operational parity (CMO services)	31 Dec 2026

9. Practical Tips for Biotech Companies Considering a U.S. CMO Partner

1. Verify FDA‑registered capacities – Request the latest 483 inspection reports for any prospective facility.
2. Assess technology compatibility – Ensure the CMO’s platform (e.g., ADC, viral vector) aligns with your pipeline’s modality.
3. Demand transparent cost models – Look for breakdowns of facility fees,material costs,and potential volume discounts.
4. prioritize data integrity – Choose partners that implement real‑time data capture and electronic batch records (EBR).
5. Plan for regulatory hand‑offs – Establish clear responsibilities for IND‑enabling studies versus commercial filing support.

10. Future Outlook

• Expansion beyond California: Samsung biologics has indicated interest in a second U.S. site (potentially in North Carolina) to serve the growing cell‑therapy hub.
• R&D collaboration: Joint research agreements between Samsung’s Biologics R&D center in Suwon and HGS’s genomics team are slated to begin Q3 2026, focusing on CRISPR‑based gene therapies.
• Sustainability initiatives: Both entities will adopt Samsung’s “Green Biomanufacturing” standards, targeting a 25 % reduction in water usage and a 15 % cut in energy consumption by 2028.