Isotopia’s Aseptic Plant
Isotopia’s aseptic plant is a leading production center for a variety of cold kits used in nuclear theranostics. The plant is strategically important to our business, enabling us to meet the growing local and global demand for customized theranostic solutions.
Acquired by Isotopia in 2019 from a renowned government-owned company, the plant has since undergone significant enhancements. Isotopia has expanded its workforce, renewed infrastructure, applied cutting-edge technologies, and successfully brought several radiopharmaceutical products to market.
The aseptic plant also offers advanced contract manufacturing services (CMO), supporting end-to-end production. These services include planning and procurement, state-of-the-art microbiology and chemistry laboratories, quality control, engineering services, packaging, and the release of final products tailored to customer needs.
Our aseptic plant:
- Complies with cGMP regulations
- Is certified by the FDA, Israeli MoH, and EMA
- Offers comprehensiveontract manufacturing services
We offer a complete array of manufacturing services for pharmaceutical purposes, fully customized to your specific needs.
Our services provide access to advanced technology, pharmaceutical expertise, faster lead times, and optimal return on investment.
Our extensive capabilities in contract manufacturing allow us to offer complete life cycle solutions, including:
- Manufacturing services
- Sourcing materials
- Microbiology and chemistry laboratories
- Development of analytical testing methods and optimized manufacturing procedures
- Equipment procurement and validation
- Supplier identification and qualification audits
Partnering with Isotopia ensures a seamless transition from clinical production to commercial manufacturing:
- Development of analytical testing methods and optimized manufacturing procedures
- Equipment procurement and validation
- Supplier identification and qualification audits
I want more details please
