Aruvant Chooses Lonza to Manufacture ARU-1801, a Potentially Curative Treatment for Sickle Cell Disease, for Pivotal Trial
January 18, 2021 at 09:00 am
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Aruvant Sciences and Lonza announced their agreement in support of ARU-1801, Aruvant's one-time investigational gene therapy for sickle cell disease (SCD). Aruvant has chosen Lonza to help develop and manufacture ARU-1801 for its upcoming pivotal trial. Aruvant is building a hybrid supply model that is led by the company's cell and gene therapy scientists and leverages specialized external suppliers. The company has expanded the internal technical and operational organization with experts in vector and cell manufacturing, analytics, quality, supply and regulatory affairs. To complement the internal capabilities, Aruvant is partnering with contract development manufacturing organizations. The strategic long-term manufacturing agreement with Lonza is a critical step to advancing the clinical development of ARU-1801 for sickle cell patients. Under Aruvant's direction, Lonza has begun process development and technology transfer activities from its Houston center of excellence to help establish robust manufacturing for ARU-1801. Once complete, Lonza will deliver cGMP material supply for the pivotal clinical trial.
Lonza Group AG is one of the world leaders of the development, production and marketing of chemical products. Net sales break down by family of products and services as follows:
- bio-pharmaceuticals (55.4%): exclusive syntheses, microbiological fermentation products , mammalian cell cultures, etc.;
- capsules and dosing solutions for biopharmaceuticals, drugs and nutrition products (17.3%). In addition, the group offers nutritional ingredients;
- small molecule drug substances (13.4%);
- technologies and platforms for manufacturing processes and production of cell and gene therapies (10.4%);
- other (3.5%).
Net sales are distributed geographically as follows: Switzerland (17.4%), Europe (31.7%), the United States (31.8%), the Americas (3.2%), Japan (8.1%), Asia (7.5%) and other (0.3%).