Skip to content

Home / CDMO solutions / Fill finish

Aseptic fill finish

We provide Annex 1-aligned, isolator-based sterile fill finish with a technical team that has released over 150 million doses to patients worldwide. In our hands, your product is safe and your supply is guaranteed.

Sterile Fill Finish

Confidence at every turn

You set the destination. We help you get there through:

Audit readiness

Facility design, equipment selection and quality systems aligned to modern aseptic expectations, including Annex 1 principles and isolator-based filling.

Successful tech 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 programs are transferred, filled and released, helping protect every dose that reaches a patient.

Kindeva’s US manufacturing

Get more than your fill at Bridgeton

  • 155,000+ sq. ft. cGMP footprint
  • Approximately 11,000 sq. ft. of fill suites
  • Multiple laboratories and formulation suites
  • Four high-speed isolator filling lines for vials, prefilled syringes and cartridges
  • Initial 150M+ unit annual capacity
  • Integrated formulation, filling and support capabilities in one U.S. network
  • Designed with utilities to support future expansion

Bridgeton capabilities

Line number Presentation Equipment platform Key capabilities
Line 1 Prefilled syringes Optima 10-head filler
  • 300ppm
  • 20–40 million units/year
  • 0.5–50 mL syringes
  • Fill volumes down to 0.1 mL
  • Automated IPC for fill weight and stopper height
Line 2 Prefilled syringes Optima 10-head filler
  • 300ppm
  • 20–40 million units/year
  • 0.5–50 mL syringes
  • Fill volumes down to 0.1 mL
  • Automated IPC for fill weight and stopper height
Line 3 Vials Groninger 8-head filler
  • 400ppm
  • 25 – 50 million units/year
  • 2R-100H vials
  • Fill volume down to 0.1ml
  • Integrated vial crimp inspection
Line 4 Cartridges Syntegon 18-head filler
  • 300ppm
  • 20–40 million units/year
  • 1-10ml cartridges
  • Volume or brim fill capability
  • Inline stopper height inspection

Get the full scope of our scale

Use our fill finish matrix to explore how Kindeva’s vial, prefilled syringe and cartridge capabilities align with different product formats, fill volumes and development stages.

Beyond fill finish: Delivering exceptional value

Our aseptic fill finish capabilities extend beyond technical expertise. We optimize your entire production process, minimizing risk and maximizing efficiency through:

By physically separating the product path from the surrounding room environment, our fill lines are designed to support sterility assurance, reduce contamination risk and protect product quality during filling.

Integrated pre-use post-sterilization integrity testing (PUPSIT) supports confidence in filter performance before product filtration begins. Built into the filling process, this control helps confirm that critical sterile filtration steps are functioning as intended before the product reaches the container.

Our inert environment capability helps support oxygen-sensitive or otherwise sensitive formulations during processing. By enabling greater control of the product environment, this capability can help protect formulation stability and maintain product quality through fill finish.

Process data capture and statistical process control capability give teams greater visibility into process performance. This supports consistent decision-making, trend monitoring and continued process verification, helping you understand how your program is performing over time.

This level of monitoring supports process oversight during manufacturing and helps strengthen control over critical operations that can affect product quality.

Dissolved oxygen monitoring, pH monitoring and inert overlay help maintain the product conditions required for successful sterile processing by aligning formulation needs with the right process environment before filling begins.

The technical expertise to transfer. The size to scale.

Kindeva supports fill finish programs from early technical assessment through commercial supply. Our teams bring together formulation, aseptic processing, analytical, quality, regulatory and device experience to help clients identify requirements early, transfer with control and scale with confidence.

Related CDMO solutions

From development to commercial manufacturing and beyond, our CDMO solutions are designed to help your product progress with purpose.

Development

Our expert team collaborates with you, leveraging a development-by-design approach to optimize drug formulations and innovative delivery devices.

Learn more

Manufacturing

Discover scalable manufacturing solutions, from clinical trial supplies to commercial production, and state-of-the-art manufacturing facilities.

Learn more

Analytical

Comprehensive analytical testing and characterization services to ensure the quality, safety and efficacy of your drug products.

Learn more

Regulatory

Leverage comprehensive support to confidently navigate the global regulatory landscape, ensuring compliance with FDA, EMA and other international standards.

Learn more

Fill finish resources and insights

Explore our library of resources to learn more about our fill finish facilities, capabilities and expertise.

Full-service CDMO powerhouse capabilities 

Kindeva Drug Delivery is your full-service CDMO powerhouse, delivering unrivaled expertise for your combination product. Explore our services for every stage of development across device & product development, clinical supply, and commercial supply. We provide unmatched expertise and support across pulmonary & nasal, injectable, and transdermal drug-delivery platforms.  

Learn More Book a meeting

How CDMO quality systems affect your product

A CDMO’s quality management system (QMS) approach directly impacts the the products it produces. Download this article to explore Kindeva’s approach to quality and risk mitigation and learn how this philosophy enables on-time, in-full delivery of high-quality products.

Learn More Book a meeting

Predictive engineering & digital twinning in biotech

The biotechnology industry can harness advanced engineering techniques in the form of predictive engineering and digital twinning to advance drug delivery device development.   Download this article to discover:   What digital twinning is and how it works  Applications of digital twinning in other industries   How Kindeva has leveraged predictive engineering and digital twinning for drug development  […]

Learn More Book a meeting

Tech transfer commercial manufacturing mindset

Technology transfer (tech transfer) moves product and process knowledge between teams or partners and acts as a crucial bridge between ideation and commercialization. Especially for complex products like sterile injectables, a smooth tech transfer process is essential. In this white paper, discover valuable strategies to embrace a commercial manufacturing mindset from day one. Download your […]

Learn More Book a meeting

Your leading global CDMO 

See our range of CDMO services and learn how we can bring your therapy to the world. Our platform technologies span pulmonary & nasal, injectable, and transdermal delivery, with services for every stage of combination product development & manufacturing. Discover how you can combine forces with us.

Learn More Book a meeting

Let’s transform tomorrow together

Every patient deserves a brighter tomorrow. As your strategic partner, we are dedicated to building your lasting legacy and helping you fast-track healthier tomorrows. You dream it, we deliver it.