Evergreen Theragnostics, Inc. | July 17, 2021
Evergreen Theragnostics, Inc., a leading radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) has started a major strategic expansion at its Springfield, NJ manufacturing facility.
Evergreen has already started expanding to build a GMP state-of-the-art alpha emitter production center, incorporated into Evergreen's current facility, with the Evergreen Springfield Facility scheduled to open within the next two months. The expansion, which is scheduled to open in the first quarter of 2022, will strengthen Evergreen's capacity to serve alpha-based radiopharmaceutical projects from pre-clinical pharmaceutical research through commercial production and supply. Evergreen's new alpha program will research and manufacture novel radiopharmaceuticals, including Actinium-225 (Ac-225), Astatine-211 (At-211), Lead-212 (Pb-212), and Thorium-227 (Th-227).
Targeted Alpha Therapy (TAT), which uses the radionuclides mentioned above, is a growing segment of therapeutic radiopharmaceuticals owing to its unprecedented promise of improving patient clinical outcomes in cancer. This new class of medicines, however, poses significant difficulties in both clinical development and manufacturing.
The new facility was created by combining Evergreen's expertise in clinical production of TAT radiopharmaceuticals with a collaboration with Tema Sinergie, a leading supplier of radiopharmaceutical manufacturing equipment. This resulted in developing specifically made production equipment to meet the challenges associated with manufacturing alpha-emitting radiopharmaceuticals in a complete cGMP environment.
About Evergreen Theragnostics, Inc.
Evergreen Theragnostics, founded in 2019, is a leading radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) headquartered in the United States. Evergreen will offer highly reliable manufacturing services for therapeutic and centrally distributed diagnostic radiopharmaceuticals from early development through commercialization, with a state-of-the-art global GMP facility opening in Q3'21. The company was founded by a team with extensive experience in radiopharmaceutical commercialization, manufacturing process development, and regulatory affairs management.
About Tema Sinergie
Tema Sinergie, founded in 1985, is a pioneer and global leader in the design and manufacture of shielded isolators for the nuclear medicine market, consistently working to extend its proven leadership onto the market of aseptic containment isolator systems to the pharmaceutical, biotech, and ATMP business branches. The company has obtained ISO 9001 and ISO 13485 certifications.
Cancer Prevention Pharmaceuticals, CPP-1X/sul | June 29, 2020
Cancer Prevention Pharmaceuticals, Inc. (CPP), a private biotech company developing novel therapeutics to prevent cancer and other diseases, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for CPP-1X/sul for treatment of adults with familial adenomatous polyposis (FAP).
FAP is a rare genetic disease that if left untreated progresses to colorectal cancer in nearly 100% of patients. The clinical development of CPP-1X/sul was designed to establish this fixed dose combination product as a potential pharmaco-preventive drug treatment specifically for FAP patients.
“The NDA submission for our lead drug candidate, CPP-1X/sul, represents a significant milestone for FAP patients and their families,” said CPP CEO Jeff Jacob. “For most FAP patients, current medical practice involves a lifetime of periodic monitoring as well as highly invasive surgical procedures. If approved, CPP-1X/sul could provide an alternative to surgery for many patients, significantly improving their quality of life.”
PCI Pharma Services | December 15, 2021
PCI Pharma Services a leading global contract development and manufacturing organizatio announced the closing of the previously announced acquisition of Lyophilization Services of New England, Inc. a premier contract development and manufacturing organization headquartered in Bedford, New Hampshire.
This acquisition is a key step for PCI, as LSNE will expand PCI’s breadth of services as a global CDMO, building on its expertise in specialty manufacturing, clinical trial supply and pharmaceutical packaging. PCI is now able to offer integrated large and small molecule solutions for its clinical and commercial clients, including global manufacturing capabilities in complex formulations, high potency, sterile fill-finish, and lyophilization, an important manufacturing process commonly used with injectable and biologic therapies.
Founded in 1997, LSNE has an impressive history of serving global pharmaceutical, biotechnology and medical device companies. LSNE is differentiated by its high-quality cGMP aseptic fill-finish capabilities, and expertise in and ability to scale lyophilization. LSNE brings to PCI five FDA-approved facilities in the U.S. and Europe with a sixth expecting approval early in the new year. The closing of this acquisition, along with the capital commitments for significant capacity expansion and PCI’s recently announced construction of a New England Clinical Center of Excellence, will also help create a centralized hub for its Northeast clients.
The injectable CDMO market is a high-growth segment outpacing the overall pharmaceutical outsourcing market and PCI is making significant investments, like this acquisition, to respond to the evolving industry landscape. This is PCI’s fourth acquisition in three years, reinforcing the company’s commitment to add new capabilities and scale to help its clients continue bringing life-changing therapies to patients all over the world.
About PCI Pharma Services
PCI is a leading global CDMO, providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products’ speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 50 successful product launches each year and over five decades in the healthcare services business. We currently have 30 sites across seven countries and over 4,300 employees that work to bring life-changing therapies to patients. Leading technology and continued investment enable us to address global drug development needs throughout the entire product life cycle – from manufacturing capabilities through the clinical trial supply chain and into commercialization. Our clients view us as an extension of their business and a collaborative partner with the shared goal of improving patients’ lives.