The new facility will be 14,000 square feet and is designed from start to finish to meet global current Good Manufacturing Practice (cGMP) standards for radiopharmaceutical manufacturing.
Evergreen Theragnostics, located in Jersey City, New Jersey, broke ground for its new manufacturing plant in Springfield, New Jersey. Evergreen is a radiopharmaceutical Contract Development and Manufacturing Organization (CDMO).
The new facility will be 14,000 square feet and is designed from start to finish to meet global current Good Manufacturing Practice (cGMP) standards for radiopharmaceutical manufacturing. This includes both therapeutic and centrally distributed diagnostic radiopharmaceuticals. The facility will have four fully equipped production suites and three additional customizable suites, in addition to research facilities, multiple sterility lines, quality control, material storage and packaging space.
Evergreen Theragnostics was founded in 2019 as a U.S.-based radiopharmaceutical CDMO. The new facility is expected to open in 2021 and provide manufacturing services for radiopharmaceuticals ranging from early development through commercialization.
“We are excited to take one more step forward in realizing our goal of providing high quality and high reliability manufacturing of radiopharmaceuticals in North America,” said James Cook, Evergreen’s chief executive officer. “We are encouraged to see companies in our industry developing so many exciting new drugs, and are eager to provide a top-tier manufacturing service to support their efforts.”
In June, the company announced it had raised $19 million in a Series A financing round. It was made by private investors in common shares of the company.
The funds are primarily being used for the construction of the manufacturing facility.
“We are very pleased to have completed this investment round with such a supportive group of shareholders, especially in the midst of unprecedented market volatility resulting from COVID-19,” Cook said at the time. “The combination of compliance with global GMP, top industry talent, and strategic facility location, with seamless access to some of the world’s largest air transportation hubs including Newark Liberty International Airport in New Jersey and John F. Kennedy International Airport in New York, positions Evergreen Theragnostics to become a premier radiopharmaceutical manufacturing and distribution company.”
The company offers a broad range of services for centrally distributed radiopharmaceuticals from Phase 0 through commercialization. These include manufacturing process development, GMP contract manufacturing, technology transfer and method validation, regulatory support services, 21 CFR 211 compliant commercial manufacturing, national logistics and distribution, and various commercial support activities.
The new factory will be able to manufacture biologics, peptides, and small molecules radiolabeled with radionuclides of intermediate radioactive half-lives. This includes 177Lu, 131I, 123I, 124I, 89Zr, 64Cu, 67Cu, 161Tb and other.
The company’s management team includes James Cook, who served as chief operations officer and general manager of the U.S. division of Advanced Accelerator Applications (AAA) from 2014 to 2019 before joining Evergreen; Serge Lyashchenko, chief scientific officer, who is currently acting as assistant attending in the Department of Radiology within the Memorial Sloan Kettering Cancer Center’s Radiochemistry & Imaging Sciences Services; Phillip DeNoble, regulatory advisor, who has held management and leadership positions at Memorial Sloan Kettering Cancer Center, New York University, Baxter Healthcare, and Progenics. Kevin Staton is head of project management; Olena Lyaschenko is a project manager and Austin Li is the business operations manager.
