When you’re looking for the right blend of innovative know-how and flexible support for your injectable drug-device product, combine forces with Kindeva. Our investment in a new sterile injectable fill-finish facility in Bridgeton, Missouri, makes us one of only a few CDMOs who can address sterile fill, device manufacture, and final assembly in one geographic location, delivering Annex I compliance with every line. We bring together a ~1M ft2 cGMP footprint, 60+ years of experience, renowned engineers, preclinical to full-scale manufacturing capabilities, and cutting-edge technology to achieve your goals.
Built for the future
Our facility in Bridgeton, MO, is built from the ground up to address today’s most pressing challenges in aseptic injectable fill-finish manufacturing.
- Small-scale clinical, niche commercial to large commercial scale
- Fully integrated capabilities across fill-finish, product assembly, and final product in one geographic location
- Initial capacity to fill 100M+ units across vials, cartridges, & syringes, with infrastructure to support further expansion, impacting millions of patients’ lives worldwide
- 155K+ sq. ft. cGMP footprint
- Facility design principles enable patient safety and Annex I compliance (3 fully isolated high-speed filling lines with utilities for up to 7, automation, unidirectional flow, etc.)
- microBatch isolated filling line which accommodates < 2,500 batch sizes
- DEA Class II-V, controlled substance approval
Sterile filling platforms
Vials/cartridges/syringes
Kindeva offers an unmatched range of development, manufacturing, and aseptic fill-finish solutions for vials, cartridges, and syringes. We can fill any currently available ready-to-use formats, from small-scale single batches to campaign filling, up to 100mL. Our device-agnostic approach assists you in identifying the best fit for your therapy.
Delivering industry-leading automation & efficiency
When it comes to complex and high-cost drugs, we understand that you need every single drop of your product. Through strategic investments, we have achieved a high degree of automation for processes that have traditionally been manual, from PUPSIT to no-touch transfers. This allows us to increase output while reducing errors and improving efficiency. With modular filling suites, we reduce downtime and provide superior scalability.
Injectable delivery platforms
Autoinjectors
Our patented single- and dual-chamber sterile injection platforms are designed for reliability, ease of use, portability, and durability. As autoinjector innovators for more than 60 years, we leverage an unrivaled breadth of knowledge to ensure every device is of the highest quality and meets FDA combination product guidelines.
Single-Chamber Autoinjector Platforms
- Drug delivered: 0.3mL-3.0mL
- Activation: Two-step user activation/rear safety release/automatic sharp protection
- Status: Launched/on market
Dual-Chamber Autoinjector Platforms
- Drug chambers: Liquid/liquid
- Drug delivered: 0.7mL-2mL
- Injection: Intra-muscular, drugs separated in vitro and in vivo (enhanced stability and bioavailability)
- Activation: Two-step user activation/rear safety release
- Status: Launched/on market
With Kindeva, you and your patients benefit from the latest in autoinjector evolution. Our newest innovations comply with the industry standard two-step sequence of use and accommodate a wide variety of containers and fill volumes in a compact form factor.
Our newest platform at a glance:
- Two designs:
- 0.3mL to 3mL delivery
- <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
Support for non-proprietary platforms
We are committed to working with you to ensure optimal delivery of your therapy, whether it is with our platforms or a third-party device. We have extensive experience working with other platforms across all stages of development and manufacturing.
Microneedle-based drug delivery
Kindeva is leading the way in intradermal delivery, with microneedle array patches customized to your needs and specifications. Our systems allow for reliable delivery of vaccines, peptides, proteins, biologics, and small and large molecules, with options for both solid and liquid APIs.
Leverage expert analytical testing
Gain insight into your injectable product’s performance and quality through our analytical and testing services. We deliver unrivaled know-how, backed by over a century of analytical experience and expertise in working with regulatory bodies worldwide. Our services include drug content assays, extractable and leachable identification and characterization, drug content uniformity testing, medical device performance testing, and more.
Combine forces with Kindeva
Kindeva’s injectable technologies provide customized drug-delivery options to suit the needs of your patients or global health security forces — always with therapeutic requirements, reliability, and ease of use at the forefront of each solution.
We can take your product from ideation to commercialization in-house with a continuity of services that enable time and cost savings while ensuring quality.