Petach Tikva, Israel – May 6st 2021
Isotopia Molecular Imaging Limited (Isotopia) and Elgan Pharma Limited (Elgan), have entered into a long-term agreement for development and manufacturing of clinical batches of lyophilized product.
“The combination of Isotopia’s capabilities in sterile production, with high level of cGMP compliance, will enable Elgan a smooth process transfer” Says Miki Olshansky – Elgan Chief Executive Officer and founder. “We are moving to GMP production for Phase III and commercial scale in the coming months. Selecting the right partner is a critical component of a successful deployment to the market.
Isotopia has the expertise and infrastructure to allow us worldwide deployment and production excellence.
“This agreement is another demonstration of Isotopia value proposition, tailored to the needs and features of Elgan pharma, Says Tzachi Levy – Isotopia Sterile Site Manager. “Isotopia will provide Elgan the resources for successful clinical trials, and later – MAA filing.
Our confidence comes from successful product launches to international markets over the last years. Meeting Elgan team was inspirational. Their products are aimed at delivering breakthrough therapies to premature infants. We have the knowledge and expertise and we’re dedicated to their goals.”
Isotopia Molecular Imaging Ltd. is a collaboration between The Metrontario Group and some of Israel’s leading scientists in the field of radiopharmaceuticals and sterile manufacturing. The Isotopia development team is a multidisciplinary team consisting of professional Quality Assurance, Chemists, Microbiologists, Engineers Operations and Logistics. The experienced Isotopia team, together with its GMP certified plant – by the IL MOH and US FDA – and centralized radio-nuclear pharmacy, cyclotron facility, carrier free 177Lu production site, are a well-established platform for development. Isotopia creates collaborations between the scientific and medical community to further develop and experiment with new markers for imaging applications, molecular therapy and providing CMO services.
E-mail: Keren Moshkoviz, Director of Business Development @ firstname.lastname@example.org
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. The company is committed for improving outcome for infants who are Extremely Low Gestational Age Newborns (ELGANs), This means they are born more than 3 months before term.
Visit the company website @ www.elganpharma.com