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Sterile injectables
We leverage the highest quality facilities, technologies and analytical capabilities to provide exceptional support for your sterile injectable products. Our state-of-the-art facility in Bridgeton, Missouri, enables us to deliver sterile fill finish, device manufacture and final assembly in a single location, ensuring Annex 1 compliance throughout.
Injectables designed to deliver excellence
By leveraging our comprehensive solutions, over 60 years of experience and a one-million-square-foot cGMP facility, our exceptional engineers can help accelerate your injectable product’s journey from preclinical development to commercial success.
Vials, cartridges and syringes
We can aseptically fill finish any currently available ready-to-use format, from small-scale single batches to large-scale campaign filling, up to 100mL. Our device-agnostic approach helps you identify the optimal solution for your therapy.
Maximizing productivity and minimizing downtime
Through strategic investments in automation, we have optimized traditionally manual processes, increasing output while reducing errors and improving efficiency. Our modular filling suites minimize downtime and provide superior scalability, ensuring your production remains on schedule.
Our fill finish capabilities
- 300/min line speed for cartridges and syringes
- 400/min line speed for vials
- 30-500L formulations
- Brim fill and volumetric fill (cartridges)
- Gas overlay, vacuum stoppering and traditional mechanical stoppering (syringes)
- 10-headed Optima syringe filler
- 6-headed Syntegon cartridge filler
- 8-headed Groninger vial filler
- Single-use Millipore Mobius fillers
- Annex I compliance (Bridgeton facility)
A bridge to the future
Our world-class facility in Bridgeton, Missouri, features over 155,000 sq. ft. of dedicated aseptic operations space, including two state-of-the-art laboratories, two formulation suites and expansive fill suites.
Equipped with advanced sterility assurance isolators and automation technology, we prioritize patient safety in every product we produce. This investment in innovation significantly expands our fill-finish capabilities, enabling us to continue manufacturing more tomorrows.
Injectable delivery platforms: Exceptional by design
Our patented single- and dual-chamber sterile injection platforms are engineered for reliability, ease of use, portability and durability. With over 60 years of autoinjector innovation, we leverage our unparalleled expertise to ensure every device meets the highest quality standards and complies with FDA combination product guidelines.
Our latest autoinjector innovations prioritize patient comfort and ease of use. Leverage advanced designs that comply with industry-standard two-step sequences and accommodate a wide range of containers and fill volumes in a compact form factor.
Our advanced proprietary platforms at a glance:
- Two designs: 0.3mL to 3mL delivery and <0.5mL delivery
- Intramuscular or subcutaneous injection
99.999% minimum system-level reliability meets FDA emergency use guidelines - Easy adjustability of key user interfaces:
- Uncap and activation forces
- Two-step activation: Remove cap and press and hold down on the injection site
- Built for expansion: Early designs which incorporate cartridge and dual-chamber options
We are committed to optimizing the delivery of your therapy, whether through our proprietary platforms or a third-party device. We leverage our extensive experience working with various platforms across all stages of development and manufacturing to ensure a seamless and efficient process for your project.
We are pioneering intradermal drug delivery, offering customized microneedle array patches tailored to your precise specifications. Our advanced systems ensure the reliable delivery of a wide range of therapeutics, including vaccines, peptides, proteins, biologics and small and large molecules, with options for both solid and liquid APIs.
Our legacy of autoinjector innovation
From the very beginning of the autoinjector’s history, we have led the way in innovating self-administered injectables. Before the autoinjector, military personnel and allergy sufferers relied on options that were difficult to use and required a complex series of steps, delaying treatment in emergencies.
1959
Created the emergency use autoinjector
The AtroPen® was one of our first autoinjector platforms. Providing fast, reliable self-injection options in emergency situations, this platform was used by the military and then NASA in 1961 with the Project Mercury spaceflight program.
1970
Invented the ComboPen® platform
The ComboPen® platform was created to deliver medical countermeasures more efficiently in the field while navigating complex regulations.
2002
Invented the BinaJect® platform
The BinaJect® platform introduced an industry-leading dual-chamber option that enhanced stability for intramuscular injections by keeping drugs separated in vitro and in vivo.
2009
Created the TruJect™ platform
The TruJect™ platform introduced the next generation of easy and reliable single-chamber autoinjectors with integrated sharps protection.
2024
Next-generation autoinjectors designed for reliability, usability and patient experience.
Our next-generation platforms are built for expansion with options for single or dual chambers, liquid or dry APIs and prefilled syringes or cartridges.
Sterile injectable resources and insights
Explore our library of resources to learn more about our sterile injectable drug delivery capabilities and expertise.
Aseptic injectable fill-finish facility
Through strategic investments and expansions, Kindeva Drug Delivery is on the forefront of combination product innovation. Our aseptic injectable fill-finish facility in Bridgeton, Missouri, is one example of our commitment to excellence. With the addition of this facility, we are one of only a few CDMOs capable of servicing sterile fill, device manufacture, and final […]
Learn More Missed our PDA poster presentations? Unlock injectable & intradermal insights
At the 2024 PDA Annual Meeting, experts from Kindeva Drug Delivery presented our insights on injectable and intradermal drug-device combination products. Spanning holistic design for aseptic injectable fill-finish, human factors for autoinjectors, and manufacturing of microneedle array patches (MAPs), our posters showcase our latest developments and know-how across injectable drug delivery. If you missed any […]
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Sterile product introduction and tech transfers in a crowded market
The tech transfer landscape for sterile products is increasingly complex, with pressure to reduce time to market. Find out how to navigate common challenges and avoid costly delays or oversights in this presentation from our Director, Client Portfolio & Relationship Management, Kim Brown. Download your copy to explore: Benefits of a commercial manufacturing mindset How […]
Learn MoreLet’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.