Our extensive hands-on expertise is backed by nine state-of-the-art facilities across the U.S. and the U.K., providing preclinical through commercial scalability and impressive scope, with a total GMP footprint of approximately a million square feet. From increased sterile fill-finish capabilities to dry powder development, your product benefits from our combination of cutting-edge technology and high capacity.
Our global facility footprint
Select each location for a deep dive into what our facilities can offer you.
Union City
Union City is a 10,500 sq. ft. (~975 m2) research and formulation facility. We provide services in the early stages of device selection, formulation design, analytical testing, GMP release testing, and product and process development and scale-up.
Union City at a glance:
- Expertise in all stages of product development and cutting-edge technologies
- Inhalation drug delivery (IDD) development
- IDD particle engineering
- Dry powder formulation
- Liquid formulation (nebulizers)
Northridge
Northridge is a 286,000 sq. ft. (~26,570 m2) scale-up and commercial manufacturing facility. We manufacture inhalation drug delivery and transdermal drug delivery products at this location.
Northridge at a glance:
- On-site GMP Quality Control laboratory ensures we meet client expectations while being in full regulatory compliance
- pMDI/MDI pressure filling
- pMDI/MDI cold filling
- MDI packaging
- Transdermal coating
- Transdermal converting
- Transdermal packaging
Bridgeton
Opening in 2024, our new, world-class facility in Bridgeton, Missouri, offers 155,000 sq. ft. (~14,400 m2) devoted to aseptic operations, including two labs, two formulation suites, and almost 11,000 sq. ft. (~1,022 m2) of fill suites. It also houses best-in-class sterility assurance isolator and automation technology.
Bridgeton at a glance:
- Designed for max efficiency, compliance, and patient safety
- Annex 1 compliance with every line
- Isolator sterility assurance technology standard
- 3 fully isolated high-speed filling lines
- Utilities sized to support up to 7 lines
- Rapid line changeover
- Independent filling suites
- Syringe, cartridge, and vial filling
- Formulation
- Automated PUPSIT testing
Woodbury
Woodbury is a 140,000 sq. ft. (13,006 m2) research, formulation, and development facility. Kindeva also provides regulatory consultation and warehousing with room for expansion at this location.
Woodbury at a glance:
- Offers high efficiency heating and air handling, LED lighting, networked connections
- GMP clinical manufacturing space — clean room facilities with 7 process rooms
- Analytical method development and validation
- Extractables and leachables characterization
- Stability chambers with 24/7 monitoring (across full range of ICH stability conditions)
- Phase I intradermal manufacturing
- Plume geometry/spray pattern testing (SprayView)
- Transdermal drug-in adhesive systems, integrated patch overlay systems, and gel patches
- Intradermal solid and liquid formulations delivered
- COMING SOON: Lab scale 152a propellant filling
Brentwood
Brentwood is a 91,760 sq. ft. (8,525 m2) aseptic operating and support manufacturing facility. It also includes warehousing and administrative offices on-site.
Brentwood at a glance:
- Fully licensed and integrated single- and dual-chamber autoinjector capability
- Formulation
- Sterile filtration
- Aseptic processing of autoinjector drug cartridges
- Engineering
- Quality control labs
Columbia
The Columbia, Maryland, facility is a 17,828 sq. ft. (1,656 m2) building that houses Kindeva’s primary business and administrative offices. Many of our company’s leadership team operate out of this location, as do key members of our device development staff.
Columbia at a glance:
- Central hub for our top 5 global combination product CDMO
- Extensive history of innovation and technical knowledge
- Dynamic drug-device platform development solutions
- Regulatory consultation
- Sustainability initiatives
Maryland Heights
Maryland Heights is a 174,850 sq. ft. (16,244 m2) inspection, device assembly, and packaging facility that manufactures finished autoinjector units. It also houses administrative offices.
Maryland Heights at a glance:
- Offers regulatory, finance, environmental health and safety, and global trade support
- Engineering and product development
- Inspection
- Labeling
- Packaging
- Warehousing
- Distribution
Clitheroe
Clitheroe is a 51,500 sq. ft. (4,785 m2) scale-up and commercial manufacturing facility. It is one of two Kindeva facilities located in the United Kingdom.
Clitheroe at a glance:
- Specializing in small and large drug-delivery device solutions and innovations
- pMDI/MDI valve manufacturing
- pMDI/MDI can manufacturing
- pMDI/MDI sleeved can manufacturing
- pMDI coated can manufacturing
Loughborough
Loughborough is a 150,000 sq. ft. (13,935 m2) research, formulation, development, scale-up manufacturing, and commercial manufacturing facility. It is one of two Kindeva locations in the United Kingdom, and it includes an extensive cleanroom facility.
Loughborough at a glance:
- Offers on-site CMC strategy and regulatory department with global product registration experience
- Independent quality organization
- MPS knowledge and capabilities
- Commercial quality control
- Microbiology laboratories
- Analytical method development and validation
- MDI cold filling, packaging, actuators, and nasal
- BAI packaging
- IDD research and development
- Stability chambers with 24/7 monitoring (across full range of ICH stability conditions)
- On-site QC laboratory and contract lab (pilot scale filling with any propellant — 134a, 227, 152a, 1234ze)
- Plume geometry/spray pattern testing (Spraytech and Oxford Lasers)
- COMING SOON: pMDI pressure filling (including 152a)
The power behind your product.
Your product is expertly developed using only the most cutting-edge technology available.
Bringing best in class sterile fill-finish to Bridgeton
Introducing our new, world-class facility in Bridgeton, Missouri!
Opening in 2024, it includes more than 155,000 sq. ft. of dedicated aseptic operations space: two labs, two formulation suites, and approximately 11,000 sq. ft. of fill suites.
And with our world-class sterility assurance isolator and automation technology, Kindeva ensures patient safety is always a priority in the products we produce. This investment in innovation greatly expands our fill-finish capabilities while providing additional space for future expansion.
Click on the Bridgeton location on the map above for even more details!
