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Bridgeton aseptic fill finish manufacturing facility

Designed specifically for aseptic manufacturing without compromise, Bridgeton combines dedicated fill finish capacity, modern contamination control strategies and room for future growth, all supported by teams with deep injectable manufacturing experience.

The place to be for fill finish

Designed for audit readiness

Bridgeton combines Annex 1-aligned design principles, isolator technology, integrated controls and experienced quality oversight to support inspection-ready operations.

Made for reliable supply

The site has 155,000+ sq. ft. of cGMP space, four high-speed isolator filling lines and infrastructure designed for future capacity expansion.

Built on a foundation of fill finish expertise

Bridgeton is supported by a team of fill finish experts with proven experience in formulation, aseptic processing, technology transfer, analytical, regulatory, quality and device support.

Modular by design

The uncompromising modular site design supports scheduling flexibility and allows maintenance activities to be managed without affecting broader site operations.

Bridgeton was built for this

155,000+ sq. ft. dedicated aseptic operations space
11,000 sq. ft. fill suites
Multiple laboratories and formulation suites
Four high-speed isolator filling lines
Expansion room and utilities for up to seven filling lines
Vial, prefilled syringe and cartridge capabilities

See more on our fill finish capabilities

Bridgeton capabilities

Presentation	Equipment platform	Key capabilities
Prefilled syringes	Optima 10-head filler	300 ppm 30–50 million units/year 0.5–50 mL syringes Fill volume down to 0.1 mL Automated IPC for fill weight and stopper height
Prefilled syringes	Optima 10-head filler	300 ppm 30–50 million units/year 0.5–50 mL syringes Fill volumes down to 0.1 mL Automated IPC for fill weight and stopper height
Vials	Groninger 8-head filler	400 ppm 25–50 million units/year 2R–100H vials Fill volume down to 0.1 mL Integrated vial crimp inspection
Cartridges	Syntegon 18-head filler	300 ppm 20–50 million units/year 1–10 mL cartridges Volume or brim fill capability Inline stopper height inspection

world-class sterile injectable facility Kindeva Bridgeton facility

Experience Bridgeton for yourself

Step inside our Bridgeton facility to see how dedicated fill finish infrastructure, isolator-based processing and scalable manufacturing capacity come together to support modern injectable manufacturing.

Where expertise lives

Behind Bridgeton’s infrastructure is a team of manufacturing, operational and quality leaders with decades of experience supporting injectable products and sterile manufacturing programs.

Their combined expertise helps customers navigate technology transfer, contamination control, scale-up and commercial supply, ensuring every program is supported by people who understand both the technical and operational realities of sterile manufacturing.

David Stevens

Chief Executive Officer

20+ years of CRO/CDMO leadership With experience spanning biologics, viral-based therapies and sterile drug products. His previous roles at Charles River Laboratories and Arranta Bio give him deep experience scaling regulated development and manufacturing organizations, helping guide Kindeva’s growth across aseptic fill finish and integrated drug delivery.

Melanie Cerullo

Chief Quality Officer

25+ years of pharmaceutical quality and regulatory leadership With experience spanning quality assurance, quality control, regulatory compliance, aseptic processing and current Good Manufacturing Practice. Her previous leadership roles at ReciBioPharm, Wave Life Sciences and Amgen help her embed prevention and proactive control across Kindeva’s multi-platform manufacturing network.

Tommy Shornak

Senior Vice President Injectables

20 years of sterile manufacturing and operations leadership With experience spanning sterile filling, formulation, production, technical operations and site management. His previous leadership roles at Thermo Fisher Scientific and Albany Molecular Research Inc. help him connect customer needs with practical fill finish execution.

John Wichelt

Vice President & General Manager of Bridgeton

25+ years of pharmaceutical and biotechnology operations leadership With experience spanning sterile manufacturing, facility expansion, qualification and site operations. His previous role at Grand River Aseptic Manufacturing shaped his understanding of large-scale fill finish facility design, construction and readiness, helping ensure Bridgeton is prepared to support complex fill finish programs.

Patrick McNally

Vice President Quality, Parenteral Technologies Business Unit

30+ years of pharmaceutical quality and regulatory leadership With experience spanning quality assurance, quality control, regulatory compliance, validation and inspection readiness. His previous leadership roles at Thermo Fisher Scientific, Catalent Pharma Solutions and Mallinckrodt Pharmaceuticals help him build quality systems that support compliant, reliable manufacturing across Kindeva’s parenteral technologies platform.

Integrated manufacturing support

Bridgeton is supported by experienced technical teams, robust quality systems, integrated inspection and packaging capabilities, and regulatory expertise that help ensure consistent product delivery.

Quality and regulatory

Let's transform tomorrow together

Every injectable product has the potential to make a meaningful impact on patients’ lives. As your fill finish partner, we’re committed to helping you navigate manufacturing complexity and build a pathway to reliable commercial supply.