Evergreen Theragnostics, Inc., a leading radiopharmaceutical Contract Development and Manufacturing Organization (CDMO), has undertaken an important strategic expansion at its manufacturing facility in Springfield, NJ
With the Evergreen Springfield Facility set to open within the next two months, Evergreen has already begun expansion to build a GMP state-of-the-art alpha emitter production center, which will be integrated into Evergreen’s existing facility. The addition, opening in Q1 2022, will bolster Evergreen’s ability to support alpha based radiopharmaceutical programs from pre-clinical pharmaceutical development to commercial manufacture and supply. The scope of novel radiopharmaceuticals to be developed and manufactured in Evergreen’s new alpha program includes those containing Actinium-225 (Ac-225), Astatine-211 (At-211), Lead-212 (Pb-212), and Thorium-227 (Th-227).
Targeted Alpha Therapy (TAT), utilizing the above radionuclides, represents a growing segment of therapeutic radiopharmaceuticals because of its unprecedented promise of improving patient clinical outcomes in the field of oncology. However, this new class of drugs presents unique challenges for both clinical development and manufacturing.
The new center was designed by leveraging Evergreen’s experience in the clinical manufacture of TAT radiopharmaceuticals and by partnering with Tema Sinergie, a leading provider of radiopharmaceutical manufacturing equipment. This led to the design of uniquely customized production equipment to address the challenges associated with the manufacture of alpha emitting radiopharmaceuticals in a full cGMP environment.
“Customization of isolator technology to suit alpha emitters has become one of the major focuses of our development efforts at Tema, taking advantage of both the long experience in the design and manufacture of shielded isolators for radiopharmaceuticals, and the cutting-edge technology of the aseptic containment isolator systems, specifically developed for pharmaceutical, biotechnology, and chemical applications. The collaboration with experts from Evergreen allowed us to deepen our understanding of the unique requirements for such an ambitious alpha project to allow for optimal final design,” said Stefano Piancastelli, Tema Sinergie CEO and Massimiliano Carriero, Head of Pharma/ATMP Business Unit.
“The goal of our TAT CDMO program is to be the leader in providing seamless clinical manufacturing solutions to our customers, directly addressing the challenges associated with availability of the TAT agent itself, and, in turn, enabling our customers to focus on the clinical aspects of novel alpha radiopharmaceutical development. We firmly believe that this approach will greatly accelerate the delivery of novel treatments to patients,” said James Cook, Evergreen Theragnostics CEO.
About Evergreen Theragnostics, Inc.
Evergreen Theragnostics, established in 2019, is a leading US-based radiopharmaceutical Contract Development and Manufacturing Organization (CDMO). With a state-of-the-art global GMP facility opening in Q3’21, Evergreen will provide highly reliable manufacturing services for therapeutic and centrally distributed diagnostic radiopharmaceuticals, from early development through commercialization. The company was founded by a team that brings a strong track record in theragnostic radiopharmaceutical commercialization, manufacturing process development, and regulatory affairs management. For more information, please visit www.evergreentgn.com.
About Tema Sinergie
Established in 1985, Tema Sinergie is a pioneer and world leader in the design and manufacture of shielded isolators for the nuclear medicine market, consistently working to expand its confirmed leadership onto the market of aseptic containment isolator systems to the pharmaceutical, biotech, and ATMP business branches. The company is certified according to international standards ISO 9001 and ISO 13485. For more information, please visit www.temasinergie.com.
