When you’re looking for the right blend of combination product experience and innovative know-how for your injectable drug delivery product, combine forces with Kindeva.
Whether leveraging our proprietary platform technology or working with you to optimize your existing technology to meet patient use and product needs, our high-capacity and industry-leading aseptic capabilities guide Annex I compliance and ensure OTIF. Kindeva Drug Delivery brings together advanced facilities, renowned engineers, preclinical to full-scale manufacturing capabilities, and cutting-edge technology to achieve your goals.
Injectable delivery platforms
Autoinjectors
Our single- and dual-chamber sterile injection platforms are designed for reliability, ease of use, portability, and durability, and our patented technologies are world class. 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 capable of meeting FDA combination product guidelines.
Single-Chamber Autoinjector Platforms – TruJect™
- 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 – BinaJect®
- 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 were designed to meet FDA Essential Performance Requirements with improved reliability, 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.
With platforms (commercialized and in development) designed to provide intramuscular and subcutaneous drug delivery, use of industry standard 1mL and 2.25mL staked needle prefilled syringes, and form factor based on decades of experience, these future-forward delivery devices meet your needs for most injectable drugs.
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
Vials / cartridges / syringes
We offer development, manufacturing, and aseptic fill-finish for vials, cartridges, and syringes, with easy accommodation of size needs from small to large, up to 100mL.
Microneedle-based drug delivery
Our microneedle drug-delivery platforms are designed for accurate dosing and reliable intradermal delivery for administration of vaccines, peptides, proteins, biologics, and small and large molecules. Whether dealing with a liquid or a solid API, our unparalleled capabilities and expertise deliver an exceptional product customized for your patients and brand.
Microneedle-based delivery has the potential to offer:
- Enhanced immunogenicity
- Elimination of cold-chain storage
- Room temperature stability
- Greater efficacy
- PK improvement
- Faster onset of action
- Better compliance & adherence
- At-home administration
- Eliminate needle phobia
Your specialized drug delivery can be realized through our extensive capacity and unparalleled capability. For solid delivery, we can accommodate 400,000 coated array patches per year for Phase I and II clinical trials and up to 1.4 million for Phase III, all manufactured in aseptic/sterile conditions. We have commercial manufacturing capabilities for production of ~14 million patches per year. Plus, our custom applicators ensure consistent needle depth for better efficacy, so patients always receive accurate delivery.
Building the future
Our capabilities are expanding with our new, aseptic center of excellence in Bridgeton, Missouri.
- 155,000 square feet
- Syringe, cartridge, and vial filling
- 3 fully isolated high-speed fillers (Phase I)
- Each suite operates independently
- Utilities to support up to 7 filling suites (Phase II+)
- 13,000 square feet of uncommitted space in the existing footprint for dedicated/custom aseptic operations (Phase II+)
- Leading technology: isolators, ionized hydrogen peroxide, disposable formulation tank bagging system, automated/integrated PUPSIT filter testing
- Cold storage
- DEA Class II-V, controlled substance
- Designed for max efficiency, compliance, and patient safety
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 enables time and cost savings while ensuring quality.