Aseptic injectable fill-finish facility

Built for the future of
injectable manufacturing

Bridgeton highlights

100M+

Unit Initial Capacity

~155K+ SQ

cGMP Footprint, With 13K+ sq. ft. of Uncommitted Space for Custom Build-Out

3

Isolator High-Speed Filling Lines, with Utilities to Support Up to 7 Lines

1

MicroBatch Syntegon Isolated Filling Line for Batch Sizes <2,500

~300/MIN

Line Speed Cartridges and Syringes & 400/min Line Speed for Vials

$200M+

Investment

Annex 1

compliant equipment and facility

Tour our state-of-the art facility in Bridgeton, MO

Unmatched integration across injectable capabilities

Shipping products and supplies between providers increases carbon footprint and product cycle time, complicating logistics and introducing opportunities for breakdowns during multiple handoffs. By integrating our sterile injectable operations across our St. Louis facilities, our partners benefit from formulation through final packaging. 

A sneak peek inside our Bridgeton facility

Watch this video for an overview of our new facility, with an inside look at its construction and features.

Get a more detailed view of our capabilities and capacity. 

Elevating the standards for aseptic fill-finish

We strategically use technology at our Bridgeton facility to ensure efficiency and compliance. Each process is tailored to our partners’ needs, informed by over half a century of as one of the top sterile fill-finish companies.

Isolator integration for Annex 1 compliance 

This is one of only a few facilities globally that is entirely Annex 1 compliant. We achieve this through the use of the latest isolator technology, including both traditional glove access and gloveless/robotic options.

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Streamlining changeover through automation

Using an automated PUPSIT system integrated into the filling machines, we ensure process controls throughout filling. Each suite operates independently, allowing separate maintenance and reducing downtime to keep your production on schedule. Automated controls allow us to track individual vials and ensure quality at every point in the process.

At the forefront of AI implementation

We use artificial intelligence (AI) to break processes down into steps and evaluate each one for operator safety and risk reduction. We are continually implementing the latest technology with a focus on patient safety and process efficiency.

Designed from the ground up for today’s challenges

Our design principles informed every aspect of our facility construction, allowing us to better service our partners’ needs:

From Annex 1 compliance to DEA Class II-V, controlled substance approval, we take a future-forward approach to stay ahead of evolving requirements Quality From small scale clinical to niche commercial and large-scale commercial volumes, we provide rapid access to cGMP space Scale We are leading the way in automation with a purpose, adding tangible value with enhanced engineering controls Automation Our state-of-the-art technology and unmatched know-how keep your production on track Efficiency
quality

From Annex 1 compliance to DEA Class II-V, controlled substance approval, we take a future-forward approach to stay ahead of evolving requirements.

scale

From small scale clinical to niche commercial and large-scale commercial volumes, we provide rapid access to cGMP space.

automation

We are leading the way in automation with a purpose, adding tangible value with enhanced engineering controls.

efficiency

Our state-of-the-art technology and unmatched know-how keep your production on track.

Combine forces with a comprehensive CDMO partner

Combine Forces With Kindeva