Evergreen Theragnostics, a radiopharmaceutical contract development and manufacturing organisation based in the US, has opened a radiopharmaceutical manufacturing facility in New Jersey, US.
The facility supports the comprehensive development and commercialisation of radiopharmaceuticals, including therapeutics from preclinical and early clinical stages to full-scale manufacturing of approved drugs.
Recommended White Papers
Recommended Buyers Guides
Evergreen Theragnostics raised $19m in a Series A financing round from the private investors holding the company’s common shares in June 2020.
The proceeds were utilised in the construction of the facility.
The ground-breaking ceremony for the facility was held in September 2020. The facility was opened in September 2021.
Location
The facility is located in Springfield, New Jersey, approximately 20 miles west of New York City.
The facility is strategically positioned in New Jersey due to its accessibility to the region’s skilled pharmaceutical workforce and distribution networks worldwide.
Furthermore, the facility is close to major transportation centres such as Newark Liberty International Airport, and John F Kennedy International Airport, New York, which facilitates seamless management of raw material supply chains from the US and Europe, enabling the timely distribution of products to North American clients.
Evergreen Theragnostics radiopharmaceutical manufacturing facility details
The state-of-the-art facility, spanning an area of 14,000ft2, is spread across two floors. It encompasses 7,000ft2 of Grade B and C cleanroom manufacturing space dedicated to the production of therapeutic and diagnostic radiopharmaceuticals in compliance with the US and the EU’s current good manufacturing practice (cGMP) requirements for radiopharmaceutical production.
It is equipped with four fully loaded manufacturing suites, three additional customisable suites, a research area, full capability multiple sterility lines and quality control, as well as a warehouse and packaging area.
The facility employs an electronic quality management system and laboratory information management system and holds a licence to manage a broad spectrum of radionuclides securely.
The facility is designed to support a high production capacity, incorporating the potential for future expansion while offering a visually appealing environment for the workforce. The facility also incorporated 3D technology that offers a virtual tour of the space.
The facility is 21CFR 211 cGMP-compliant and features a dedicated radiopharmacy dispensing area for syringe delivery, direct isotope sourcing, and supply management capabilities.
Contractors involved
Colliers Engineering & Design, an engineering and architecture company, in partnership with Hodess Cleanroom Construction (HCC), a cleanroom construction company, played a pivotal role in the design and construction of the facility.
HCC collaborated with Bergman and Associates, an engineering company, and HL Turner, a construction and architecture company, on the design aspects of the facility.
HCC also undertook all phases of construction, ranging from initial site work to the completion of cleanrooms and mechanical installations for the facility.
Marketing commentary on Evergreen Theragnostics
Established in 2019, Evergreen Theragnostics provides services for centrally distributed radiopharmaceuticals from preclinical to the commercial stage.
The company’s core services include manufacturing process development, GMP contract manufacturing through a complete life cycle of the product, technology transfer and process validation, and regulatory support services.
It specialises in process automation of manufacturing radiolabelled biologics, batch size scale-up for commercial-scale production, analytical method development and validation of novel agents, as well as global logistics and distribution.
It also holds expertise in the extensive clinical production of antibodies, peptides, and radiopharmaceuticals based on small molecules, utilising alpha, beta and gamma-emitting radionuclides.
