Aseptic Plant

From New product Development to Commercial products supply

In 2019 Isotopia Molecular imaging purchased the sterile site plant which was under the government authorization and known as Soreq Nuclear Research Center (SNRC) . Under Isotopia, the site will manufacture and supply a variety of pharmaceutical products to local and international markets in the nuclear medicine field. Isotopia also cooperates with Israeli and international companies, as CMO to support all stages of product development starting with procurement services to packaging and shipment – according to customer needs. As a CMO, we can provide you a range of services design to specific needs: from locating certified suppliers up to delivery of the final product. Our facility has a variety of professional units in-house, such as: product development, operation, quality, laboratories, supply chain and engineering.

Isotopia aseptic site:
– Work according to GMP requirements
– Compliance with the Israeli MOH and FDA guidelines ( E2ES)
We can provide you:
• Customized services to product lifecycle
• Quality teams to support product development and registration processes
• Supporting the submission process with all necessary documents
• Microbiology and Chemistry laboratories
• Suitable to customer needs (you can chose the batch size, packing size, filling volume, etc.)
• Developing analytical testing methods and manufacturing procedures
• Locating suppliers and qualification audits
• Equipment purchasing and validation

AYANA Pharma

Ayana Pharma is uniquely positioned to expand the uses and efficacy of the lipid-based cytotoxic drug’s well-established clinical profile. Invented by Prof. Yechezkel Barenholtz from the Hebrew University who is also the co-founder of Ayana Pharma.http://www.integra-holdings.com/portfolio-items/ayana-pharma/

UroGen Pharma

UroGen Pharma is a clinical-stage biopharmaceutical company focused on developing novel therapies designed to change the standard of care for urological pathologies with a focus on uro-oncology. The Company has an innovative and broad pipeline of product candidates that it believes can overcome the deficiencies of current treatment options for a variety of urological conditions with a focus on uro-oncology.http://urogen.com/

POLYPID OPTIMIZED THERAPEUTICS

We are a clinical-stage pharmaceutical company focused on developing, manufacturing and commercializing novel, locally administered therapies using our transformational PLEX (Polymer-Lipid Encapsulation matriX) technology. The Company’s product pipeline candidates are designed to address unmet medical needs by pairing PLEX technology with approved pharmaceuticals which are delivered locally at predetermined release rates and durations over periods ranging from days to several months.http://www.polypid.com/

Rotem Industries Ltd.

Rotem, a longtime world leader in consumables for PET imaging, supplies cyclotrons around the world with complete packages for radiotracer production. Our product line is centered on Oxygen-18 enriched water, plastic cassettes, precursors and full reagent kits for various synthesis moduleshttp://www.rotem-medical.com/

Isorad Pharmaceutical Division

Isorad Ltd. was established 40 years ago, in order to commercialize technologies which have been developed in the SOREQ Nuclear Research Center (Soreq NRC) near Yavne, Israel. Over the years, Isorad has been involved in the following areas: Electro optical elements, Lasers, Fuel Chemical Tagging, Radiation Detection, Wind Measurement and many morehttp://www.isorad.co.il/en/

Isotopia aseptic site:
– Work according to GMP requirements
– Compliance with the Israeli MOH and FDA guidelines ( E2ES)
We can provide you:
• Customized services to product lifecycle
• Quality teams to support product development and registration processes
• Supporting the submission process with all necessary documents
• Microbiology and Chemistry laboratories
• Suitable to customer needs (you can chose the batch size, packing size, filling volume, etc.)
• Developing analytical testing methods and manufacturing procedures
• Locating suppliers and qualification audits
• Equipment purchasing and validation

AYANA Pharma

Ayana Pharma is uniquely positioned to expand the uses and efficacy of the lipid-based cytotoxic drug’s well-established clinical profile. Invented by Prof. Yechezkel Barenholtz from the Hebrew University who is also the co-founder of Ayana Pharma.http://www.integra-holdings.com/portfolio-items/ayana-pharma/

UroGen Pharma

UroGen Pharma is a clinical-stage biopharmaceutical company focused on developing novel therapies designed to change the standard of care for urological pathologies with a focus on uro-oncology. The Company has an innovative and broad pipeline of product candidates that it believes can overcome the deficiencies of current treatment options for a variety of urological conditions with a focus on uro-oncology.http://urogen.com/

POLYPID OPTIMIZED THERAPEUTICS

We are a clinical-stage pharmaceutical company focused on developing, manufacturing and commercializing novel, locally administered therapies using our transformational PLEX (Polymer-Lipid Encapsulation matriX) technology. The Company’s product pipeline candidates are designed to address unmet medical needs by pairing PLEX technology with approved pharmaceuticals which are delivered locally at predetermined release rates and durations over periods ranging from days to several months.http://www.polypid.com/

Rotem Industries Ltd.

Rotem, a longtime world leader in consumables for PET imaging, supplies cyclotrons around the world with complete packages for radiotracer production. Our product line is centered on Oxygen-18 enriched water, plastic cassettes, precursors and full reagent kits for various synthesis moduleshttp://www.rotem-medical.com/

Isorad Pharmaceutical Division

Isorad Ltd. was established 40 years ago, in order to commercialize technologies which have been developed in the SOREQ Nuclear Research Center (Soreq NRC) near Yavne, Israel. Over the years, Isorad has been involved in the following areas: Electro optical elements, Lasers, Fuel Chemical Tagging, Radiation Detection, Wind Measurement and many morehttp://www.isorad.co.il/en/