Radiopharmaceutical manufacturing facility
Evergreen Theragnostics, a radiopharmaceutical contract development and manufacturing organisation (CDMO) based in New Jersey, US, is developing a state-of-the-art radiopharmaceutical manufacturing facility in New Jersey, US.
The new facility will support the comprehensive development and commercialisation of radiopharmaceuticals, including theragnostics from pre-clinical and early clinical stage to full-scale manufacturing of approved drugs.
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 will be utilised in the construction of the new manufacturing facility.
The groundbreaking ceremony for the plant was held in September 2020, while the opening is scheduled for the third quarter of 2021.
Spanning an area of 14,000ft², the new manufacturing facility will be located in Springfield, New Jersey, approximately 20 miles (32.18km) west of New York City.
The facility was strategically positioned in New Jersey due to its accessibility to the region’s skilled pharmaceutical workforce and distribution networks worldwide.
Furthermore, the facility will be close to major transportation centres such as Newark Liberty International Airport, and John F Kennedy International Airport, New York, which will facilitate seamless management of raw material supply chains from the US and Europe. It will also enable the timely distribution of products to North American clients.
The facility will produce therapeutic and diagnostic radiopharmaceuticals in compliance with the US and the European Union’s (EU) current Good Manufacturing Practice (cGMP) requirements for radiopharmaceutical production.
It will be 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 warehouse and packaging area.
Manufacturing suites are designed to produce biologics, peptides, and small molecules radiolabelled with radionuclides of intermediate radioactive half-lives, including 177Lu, 131I,123I,124I, 89Zr, 64Cu, 67Cu, 161Tb, and others.
The facility will be 21CFR 211 cGMP-compliant and will feature a dedicated radiopharmacy dispensing area for syringe delivery, direct isotope sourcing, and supply management capabilities.
Established in 2019, Evergreen Theragnostics provides services for centrally distributed radiopharmaceuticals from pre-clinical to commercial stage.
The company’s core services include manufacturing process development, GMP contract manufacturing through complete life-cycle of the product, technology transfer and process validation, regulatory support services, 21 CFR 211-compliant commercial manufacturing, national logistics and distribution, and commercial support activities such as handling orders, demand planning and full supply chain management.
The company was formed by a team with expertise in the areas of theragnostic radiopharmaceutical marketing, developing manufacturing methods, and managing regulatory affairs.
It is specialised 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.
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