Kindeva Drug Delivery will renovate an acquired 155,000ft² facility in Bridgeton, Missouri, to expand its aseptic manufacturing capabilities.
Announced in April 2023, the project will entail an investment of more than $100m over the next four years to make the facility capable of supporting increased manufacturing of drug-device combination products and sterile fill-finish capabilities, as well as generate new jobs in the St. Louis region.
The new facility is scheduled to open in 2024. The company will gain from the Missouri Works programme during the expansion. The programme serves as a tool for companies seeking to grow and maintain their workforce. It facilitates access to capital through withholdings and tax credits specifically designed to incentivise job creation.
The new facility will be constructed at 13910 St Charles Rock Road, Bridgeton.
Kindeva’s aseptic fill-finish facility details
The new 155,000ft² (14,400m² approximately) Aseptic Center of Excellence will be dedicated to aseptic operations. It will include a 142,000ft² area for manufacturing, labs and warehousing, as well as a 12,600ft² area for custom production.
The facility will have two labs, two formulation suites and about 11,000ft² (1,022m²) of fill suites.
The formulation capabilities of the facility will include two tanks using single-use technology with magnetic levitation mixers having a mixing capacity between 30l and 500l. The facility will have single-use bags for formulation and work-in-progress (WIP) bulk storage.
The use of single-use technology can reduce time to market, lower product loss, and gentle product handling.
Future potential fill-finish capabilities include 3ml to 50ml nested syringes, 8.6mm to 18.2mm cartridges, 1.5ml to 10ml nested cartridges, 2ml to 50ml nested vials and 10ml to 50ml vials.
Additional capabilities include the Drug Enforcement Administration (DEA)-controlled substance Class II-V.
Future storage facilities will comprise approximately 400ft² of cold storage and five to six stand-up freezer units.
Technology and equipment details
The new facility will be equipped with advanced sterility assurance isolator and automation technology for maximum efficiency, compliance and patient safety.
It will feature three fully isolated high-speed filling lines, Annex 1 compliance with every line, utilities sized to support up to seven lines, rapid line changeover, independent filling suites, syringe, cartridge and vial filling, formulation, as well as automated pre-use post-sterilisation integrity testing (PUPSIT).
Acquisition details of the Bridgeton facility
Meridian, which merged with Kindeva in 2022, purchased the Bridgeton facility for about $11m from KNFH, an investment services firm based in the US, in September 2022. The facility was previously occupied by Nesher Pharmaceuticals, a pharmaceutical manufacturer, until 2021.
Marketing commentary on Kindeva Drug Delivery
Kindeva is a global contract development and manufacturing company with a focus on drug-device combination solutions. It has nine total integrated facilities across the US and the UK.
It has approximately 1,300 patents and 75 inventions in use and distributes about 100 million commercial devices a year.
The company has a total current good manufacturing practices (cGMP) footprint of approximately a million square feet with more than 2,000 employees. It develops and manufactures products in a variety of forms, including transdermal, injectable, pulmonary and nasal. It offers services in early-stage feasibility, commercial-scale drug product fill-finish, container closure system production and drug-device product assembly.
The company’s inventive work on biologics, microneedle delivery, pressurised metered-dose inhalers, autoinjectors and sustainability offer practical solutions for collaborators and patients globally.
Altaris, a healthcare investment firm, acquired Kindeva (formerly 3M Drug Delivery Systems) from 3M in 2020 and Meridian Medical Technologies from Pfizer in 2021, making them operating companies of Altaris. Kindeva and Meridian merged in December 2022, creating a global contract development and manufacturing organisation (CDMO) dedicated to drug-device combination products.