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Aseptic plant

Aseptic Manufacturing and CMO Services at Isotopia

At Isotopia, we specialize in aseptic manufacturing of a wide range of medical products, including gels, solutions, liposomes, lyophilized products, and cold kits, which are marketed worldwide. Our state-of-the-art aseptic manufacturing plant is not only home to the production of our Isoprotrace® Cold Kit for prostate cancer imaging but also serves as a trusted partner for Contract Manufacturing Organization (CMO) services. We provide biotech and pharmaceutical companies around the world with sterile drug production for both clinical trials and commercial use.

With a focus on utmost quality, safety, and compliance, we are dedicated to partnering with these companies in delivering breakthrough therapies and advancing global healthcare.

From Concept to Commercialization: Your Optimal Manufacturing Partner in Concept Development

State-of-the-Art Facilities

Our cutting-edge aseptic manufacturing plant operates under strict GMP guidelines (Israeli MOH and US FDA approved), meeting the highest industry standards for sterile drug production.

Experienced Team

Our team of experts has a proven track record in delivering high-quality sterile products. We assist with material sourcing, purchasing, process characterization, manufacturing, testing, and product release, ensuring smooth operations every step of the way.

Rigorous Quality Control

We adhere to stringent quality control measures to ensure the ultimate safety and efficacy of every product we produce.

Customized Solutions

From clinical trials to full-scale commercial manufacturing, we offer tailored solutions to meet the unique requirements of each project, ensuring flexibility in batch size, packaging, and product specifications.

Customized Solutions for Diverse Customer Needs

Whether you’re at the early stages of clinical trials or scaling up for commercial production, Isotopia’s aseptic plant provides tailored solutions for every phase of your product’s lifecycle. We are committed to driving healthcare innovation and advancing precision medicine by delivering services that meet the unique needs of pharmaceutical and biotech companies worldwide.

Our Commitment to Innovation

Isotopia’s aseptic plant is more than just a manufacturing facility — it’s a strategic partner in advancing precision medicine. Our team combines technical expertise with a passionate commitment to improving patient outcomes globally, ensuring that our customers’ groundbreaking therapies reach the people who need them most.

Let’s Bring Your Vision to Life

Ready to partner with a trusted aseptic manufacturing provider?
Contact us today to discuss your project requirements, and let’s make your vision a reality!

Contact Us Today

Our Customers

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.

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.

Polyoid

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.

Rotem

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 modules.

Isorad

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 more.

ELGAN Pharma

ELGAN Pharma is a late-stage neonatology-focused biotechnology company, lead indication going into second phase III multinational trial with pipeline of high unmet needs of premature infants. The company is dedicated to developing safe tailored therapies to address medical problems and developmental difficulties that are common in babies born very early.