SOFIE Inc., a Theranostics company, has begun construction of a new Radiopharmaceutical Contract Manufacturing Center of Excellence in Totowa, New Jersey.
The facility, located adjacent to an existing 10,000 square foot SOFIE diagnostic manufacturing site in Totowa, will be approximately 20,000 square feet (including the mechanical mezzanine and finished rooftop spaces), approximately 2,700 square feet of which will be GMP manufacturing space. The GMP space will include four cleanrooms containing isolators and hoods suitable for aseptic manufacturing to support a variety of processes, isotopes, and production scales.
Another room currently designated for solution prep, sterility, and other support can readily be converted to a fifth cleanroom. The facility will be entirely self-sufficient, containing QC, R&D, and microbiology laboratories, as well as receiving, GMP storage, shipping, and other support areas. The facility is designed to be further expandable, doubling the current footprint of cleanrooms.
According to company officials, “this development follows the completion of a strategic transaction in early 2019 with the divestiture of SOFIE’s contract manufacturing facility in Somerset, New Jersey. The new facility is designed to be suitable for efficient manufacturing of multiple therapeutic radiopharmaceuticals for numerous customers at a significantly larger scale than the previous Somerset facility.”
“Together, the two Totowa sites will total 30,000 square feet of premier radiopharmaceutical manufacturing space to support the needs of SOFIE’s pharma partners, as well forward looking for in-house theranostics. We’re excited to more fully support the burgeoning field of radioisotope-based therapeutics and diagnostics with this new facility,” said Melissa Moore, SOFIE’s Chief Technology Officer. SOFIE’s Chief Revenue Officer, Philipp Czernin, added, “The Center of Excellence is a crucial piece to our growth strategy, specifically around providing access for clinical trials of our recently acquired IP.” COE Project Manager and Sernior Director of QA Glenn Jennings said, “When completed, this site will offer our partners access to world-class development services and unparalleled radiopharmaceutical manufacturing capacity in a globally compliant facility.”
The new facility will be fully US and EU compliant to service pre-clinical, clinical, and commercial products, officials said. This facility is an integral part of SOFIE’s strategic goal of becoming the leading contract development and manufacturing partner for radiopharmaceutical companies worldwide. It also represents a significant capital investment in the growth of the company.
The new manufacturing center has been collaboratively designed and is under construction by IPS-Integrated Project Services, a leading global provider of design, engineering, procurement, construction management, and validation services for the biotechnology and pharmaceutical industries.
IPS provided full turnkey services including site selection, preliminary design through procurement, construction, and CQV activities, and the identification of modular delivery strategies to meet SOFIE’s cost and schedule objectives.
“IPS is excited to provide EPCMV services for the expansion of SOFIE’s contract manufacturing capabilities,” said IPS President and Managing Director – Americas Mark Butler. “SOFIE’s mission of delivering innovative radiopharmaceutical products in a state of art facility aligns well with IPS’ mission of providing services for client’s which deliver life-impacting products worldwide.”
The facility includes many modular components already under design and fabrication, with construction efforts scheduled to reach full deployment by June 24, 2019, and targeted for completion before the end of 2019.