QIAGEN Sciences LLC (fka QIAGEN, Inc.) - U.S. Manufacturing & Operations Hub for Sample to Insight S

📢 Key Milestones (2016-2025):
   Multiple U.S. Inc. entities were restructured as LLCs: QIAGEN, Inc. became QIAGEN LLC (Delaware); QIAGEN Sciences, Inc. became QIAGEN Sciences LLC; and QIAGEN Beverly, Inc. / QIAGEN Gaithersburg, Inc. became LLCs. In 2020, the Germantown facility underwent a $7+ million renovation and expansion to support COVID-19 testing production. In 2025, the facility's quality management system was further strengthened as part of the group-wide ISO 50001 energy management certification completion.

Company Profile (Updated April 2026)

QIAGEN Sciences LLC is the primary U.S. operating subsidiary of QIAGEN N.V., serving as the North American manufacturing and distribution headquarters for the QIAGEN Group. The entity is registered in Delaware as a Foreign Limited Liability Company and operates from 19300 Germantown Road, Germantown, Montgomery County, Maryland 20874.

The company's origins trace back to QIAGEN, Inc., a California corporation that historically served as the U.S. operating arm and customer contact point (parties in the United States could contact QIAGEN, Inc. in Valencia, California at 800-426-8157). Over time, this entity was restructured and renamed QIAGEN LLC (Delaware), and large-scale manufacturing operations were consolidated under QIAGEN Sciences LLC. Today, QIAGEN Sciences LLC functions alongside QIAGEN North American Holdings, Inc. (California, established February 24, 2000) as the core U.S. corporate structure within the QIAGEN Group.

Historical Evolution of U.S. Entities:

- 2000 (February): QIAGEN North American Holdings, Inc. established in California as the U.S. holding company; QIAGEN Sciences, Inc. established as the North American manufacturing and R&D headquarters

- 2002: QIAGEN Sciences, Inc. manufacturing facility in Germantown, Maryland completed at a cost of $57.5 million; manufacturing activities began during Q2 2002

- 2007: QIAGEN North American Holdings, Inc. acquired Digene Corporation (Gaithersburg, MD) for $1.6 billion, integrating HPV diagnostic leadership

- 2014: QIAGEN consolidated three Maryland sites (Germantown, Gaithersburg, Frederick) into two campuses, investing $10 million and passing FDA pre-approval inspection for the Germantown facility to manufacture the digene HC2 HPV Test with zero 483 observations

- 2015: Administrative renovations completed at Germantown; total recent commitment in Maryland reACHed $50 million

- 2016-2017: Corporate restructuring: QIAGEN, Inc. became QIAGEN LLC (Delaware); QIAGEN Sciences, Inc. became QIAGEN Sciences LLC; QIAGEN Beverly, Inc. became QIAGEN Beverly, LLC; QIAGEN Gaithersburg, Inc. became QIAGEN Gaithersburg, LLC

- 2020: Germantown facility expanded with $7+ million investment to accommodate COVID-19 testing production; 146,000-square-foot manufacturing wing renovated

- 2025: Group-wide ISO 50001 energy management certification completed, covering U.S. manufacturing operations

Core Mission: To manufacture and supply high-quality sample and assay technologies for the North American market and global export, supporting molecular diagnostics, life sciences research, and applied testing with regulatory-compliant production standards.

Germantown Manufacturing Campus

Facility Overview

Address: 19300 Germantown Road, Germantown, MD 20874, USA

Site: 24-acre owned campus

Building Area: 285,000 square feet (campus-style arrangement of multiple buildings)

Expansion Capacity: Room for future expansion up to 300,000 square feet

Primary Functions:

- Large-scale manufacturing of diagnostic consumAbles and life sciences reagents

- Warehousing and North American distribution logistics

- Research and development for molecular diagnostics

- Administration of U.S. operations

- Service Solutions and training center (leased additional 13,500 sq. ft. on campus)

Production Capabilities

The Germantown facility manufactures consumable products under the same rigorous standards as QIAGEN GmbH in Hilden, Germany:

- Sample Preparation Kits: Nucleic acid purification reagents and components

- PCR & qPCR Reagents: Master mixes and enzyme formulations for molecular amplification

- Diagnostic Assay Components: digene HC2 HPV Test reagents, QuantiFERON-TB Gold assay materials, and QIAstat-Dx panel components

- Stabilization and Processing Reagents: Solutions for sample collection, transport, and preservation

Quality Management & Certifications

Products manufactured at QIAGEN Sciences LLC in Maryland are produced under:

- ISO 9001:2015 — Quality management systems

- ISO 13485:2016 — Medical device quality management

- MDSAP (Medical Device Single Audit Program) — Multi-jurisdictional regulatory compliance (U.S., Canada, Brazil, Australia, Japan)

- FDA cGMP (current Good Manufacturing Practice) — Special cGMP production areas within the Germantown facility for molecular diagnostic consumables

- ISO 50001 — Energy management standard (completed group-wide implementation in 2025, including U.S. sites)

The facility passed an FDA pre-approval inspection in 2014 with zero 483 observations for the manufacture of the digene HC2 HPV Test, demonstrating exemplary regulatory compliance.

U.S. Facility Network

In addition to the flagship Germantown campus, QIAGEN operates several other U.S. facilities:

Frederick, Maryland

- Area: 76,500 square feet (leased)

- Purpose: Development, Service Solutions, manufacturing, warehousing and distribution

- Focus: R&D and manufacturing of molecular testing products for life sciences research

- Certification: LEED Gold certification achieved in 2024 for new business expansion

Beverly, Massachusetts

- Area: 44,000 square feet (leased)

- Purpose: Enzyme manufacturing

- Focus: Production of specialized enzymes for molecular biology applications

Redwood City, California

- Area: 12,700 square feet (leased)

- Purpose: Bioinformatics software development

- Focus: QIAGEN Digital Insights (QDI) platform development, CLC Genomics Workbench, and genomic data interpretation tools

Corporate Structure & Governance

Legal Name (Operating Entity): QIAGEN Sciences LLC

Legal Form: Foreign Limited Liability Company (Delaware-registered, operating in Maryland)

Registration: Delaware (U.S.); Foreign LLC authority in Maryland

Company Number (Maryland): Z12845723

Registered Agent: CSC-Lawyers Incorporating Service Company

Ultimate Parent: QIAGEN N.V. (Venlo, Netherlands)

U.S. Holding Company: QIAGEN North American Holdings, Inc. (California, established February 24, 2000)

- Address: 27220 Turnberry Lane #200, Valencia, CA 91355

- Phone: (661) 702-3000

- Employees: ~250

- Annual Revenue (D&B): ~$217.8 million

Also Known As (Predecessor): QIAGEN LLC (fka QIAGEN, Inc.)

Industry: Biotechnology / Molecular Diagnostics / Life Sciences Manufacturing

U.S. Market Contribution

The Americas region, led by U.S. operations, is QIAGEN's largest market:

- Revenue Share: ~52% of QIAGEN N.V. global net sales (2024)

- Market Position: United States drives almost half of QIAGEN's global sales

- Customer Base: Academic research institutions, pharmaceutical and biotechnology companies, molecular diagnostics laboratories, applied testing markets (forensics, veterinary, food safety)

- Strategic Importance: Germantown facility is one of two primary global consumable manufacturing sites (alongside Hilden, Germany)

Sustainability & Energy Management

QIAGEN Sciences LLC participates in QIAGEN's group-wide environmental strategy:

- Building Management Systems: Implemented in 2024 at Germantown to improve and reduce energy demand for heating and cooling

- Equipment Modernization: Replaced natural gas-fueled equipment with electric alternatives

- Green Building Certification: The Frederick site achieved LEED Gold certification in 2024

- Renewable Energy: In 2024, QIAGEN purchased Energy Attribute Certificates (EACs) for all U.S. facilities, sourced from unspecified renewable electricity

- Carbon Goals: Contributing to group-wide Science Based Targets initiative (SBTi) of 42% reduction in Scope 1 and 2 GHG emissions by 2030

2026 Operational Outlook

- Capacity Utilization: Leverage expanded Germantown capacity to support QIAstat-Dx, QIAcuity, and QuantiFERON global demand growth

- Operational Efficiency: Continue investments in automated and interchangeable production equipment to improve manufacturing efficiency

- Regulatory Compliance: Maintain FDA cGMP and MDSAP compliance amid evolving U.S. FDA and international regulatory requirements

- Sustainability: Progress toward ISO 14001 Environmental Management System certification for Germantown and Manchester (UK) sites

- Supply Chain Resilience: Strengthen North American distribution and logistics capabilities to serve the U.S. market and global export channels

Contact Information

QIAGEN Sciences LLC / U.S. Operations (Maryland)

Address: 19300 Germantown Road, Germantown, MD 20874, USA

Phone: +1-800-426-8157 (Customer Service)

Website: www.qiagen.com

QIAGEN North American Holdings, Inc. (California)

Address: 27220 Turnberry Lane #200, Valencia, CA 91355, USA

Phone: (661) 702-3000

Parent Company (Investor Relations)

QIAGEN N.V.

Address: Hulsterweg 82, 5912 PL Venlo, The Netherlands

Investor Relations: corporate.qiagen.com/investors

Email: ir@qiagen.com

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