Sterile fill finish manufacturing for injectable drug products
Backed by teams that have supported the release of more than 150 million injectable units worldwide, Kindeva provides sterile fill finish manufacturing designed to help you scale with confidence from clinical production through commercial supply.
The place to be for fill finish
Purpose-built fill finish capacity across prefilled syringes, vials and cartridges, supported by modular manufacturing suites, isolator-based processing and integrated quality systems.
Designed for every detail
From formulation and technology transfer to commercial manufacturing, Kindeva helps establish manufacturing strategies designed for long-term product success.
Our commitment to you
Every sterile fill finish program depends on strong technical foundations, clear communication and consistent execution. Built on decades of experience supporting injectable products, these commitments guide every program we deliver, regardless of molecule or scale.
Audit readiness
Facility design and quality systems aligned to modern aseptic expectations, including Annex 1 principles and isolator-based filling.
Streamlined technology transfer
Cross-functional technical teams help transfer established processes into our facility by aligning formulation requirements, analytical methods, regulatory documentation and qualification planning.
Reliable supply
Purpose-built capacity across vials, prefilled syringes and cartridges, with modular suites and process monitoring designed to support programs from clinical development through commercial supply.
Patient safety
Sterility assurance, contamination control, analytical testing and quality oversight are built into the way products are transferred, filled and released, helping protect every dose that reaches a patient.
Our state-of-the-art fill finish facility at a glance
Purpose-built for aseptic manufacturing and designed for future growth.
- Built on a legacy of injectable manufacturing expertise
- 150M+ annual unit capacity
- Clinical through commercial manufacturing
- Four high-speed isolator filling lines
- Supported by integrated assembly and packaging expertise
- Expansion capability for up to seven lines
- Small molecules, biologics, peptides, vaccines and emergency-use therapies
Explore our fill finish capabilities
We support sterile fill finish manufacturing with dedicated capabilities for formulation, technology transfer, prefilled syringes, vials and cartridges. Our approach is built around matching each product to the right line, right scale and right controls.
Formulation
Our formulation specialists and capabilities help establish the conditions needed for successful aseptic processing and long-term manufacturing performance.
Learn more
Technology transfer
Through cross-functional project management, risk assessment and process understanding, we help prepare products for consistent commercial production.
Learn morePrefilled syringes
Dedicated syringe filling lines that support ready-to-use components, automated checks and commercial-scale output.
Learn more
Vials
Flexible vial filling for a broad range of vial formats, with integrated inspection and process data capture.
Learn more
Cartridges
Dedicated cartridge filling for device-based injectable products, with inline inspection and controlled filling options.
Learn moreFind your path to commercial manufacturing
Explore the interactive guide to discover the fill finish strategy and infrastructure that best align with your product, timeline and manufacturing goals.
Bridgeton capabilities
|
Line |
Presentation |
Equipment platform |
Key capabilities |
|---|---|---|---|
|
|
Prefilled syringes |
Optima 10-head filler |
|
|
|
Prefilled syringes |
Optima 10-head filler |
|
|
|
Vials |
Groninger 8-head filler |
|
|
|
Cartridges |
Syntegon 18-head filler |
|
Supporting services
Our supporting expertise and services help ensure sterile injectable programs progress efficiently from development through commercial manufacturing, providing the technical, quality and regulatory foundations needed to support product success.
Resources and insights
Explore technical content and expert perspectives covering sterile fill finish manufacturing, technology transfer, contamination control and more.
Webinar | Beyond the filling suite: How modular facility design supports sterile manufacturing success
Sterile manufacturing requirements are fast evolving, which means that many organizations are reassessing whether their legacy facilities can support future operational and regulatory demands. In this webinar, John Wichelt, Vice President and General Manager at Kindeva’s Bridgeton site, explores what a modern sterile fill finish facility needs to look like in this new era. Drawing […]
Learn More
Q&A: Navigating tech transfer and production pitfalls
Successful tech transfer alignment requires robust risk management and precise operational planning. When communication gaps or unforeseen supply chain hurdles emerge, project timelines and product quality are often the first to be affected. In this Q&A, we explore the common pitfalls of pharmaceutical tech transfers, including how to protect critical milestones without compromising safety and […]
Learn More
What does Annex 1 mean for sterile drug product manufacturing?
Annex 1 compliance remains a key priority for companies working in sterile drug product manufacturing. But recognizing how fundamentally expectations around sterility assurance have changed may be the most significant challenge companies face. Revisions to the EU GMP Annex 1 requirements now move beyond individual compliance activities and place greater emphasis on how contamination risks […]
Learn More
Video tour | Explore Kindeva’s US manufacturing network
As a purpose-fueled, people-centric drug delivery CDMO, we are dedicated to advancing programs that help fast-track healthier tomorrows. Our US facilities play a vital role in delivering this commitment, providing specialized environments, technical depth and operational excellence that extend beyond manufacturing. Our US sites are strategically located and designed to support complex drug delivery programs […]
Learn More
Explore our world-class sterile injectable facility in Bridgeton, Missouri | Video tour
Spanning over 155,000 sq. ft. of dedicated aseptic operations space, our Bridgeton, MO facility brings together leading expertise, advanced automation and Annex 1-compliant isolator technology to help support growing global demand for sterile injectables. Designed to deliver excellence from floor to ceiling, Bridgeton seamlessly connects development and delivery through flexible fill finish infrastructure that helps […]
Learn More
PharmaSource podcast with Tommy Schornak
Today’s pharmaceutical companies must manage tight timelines and high demand for products, as well as shifting regulatory requirements and an increasingly complex global supply chain. How can contract development and manufacturing organizations (CDMOs) rise to this challenge and provide the support they need? In this podcast with PharmaSource, Tommy Shornak, Senior Vice President, Sterile Injectables, […]
Learn MoreLet’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.