Basel, Switzerland and Aprilia, Italy, 05 September, 2016 / B3C newswire / -- IBI-Lorenzini has entered into a partnership with the Swiss contract development and manufacturing organisation, Celonic, to establish high performance cell lines for R&D.
Cell line development is one of the most challenging phases, especially when subsequent GMP compliance is required. To boost and support successful commercial introduction of biological drugs to the market, Celonic has developed CHOvolution™, a cell line kit that can be used for a broad range of applications, ranging from non-GMP R&D testing to GMP development and commercial market supply – with a technical and scientific support system to help with every step.
“This agreement is a major step for IBI-Lorenzini. This partnership will strengthen the capabilities of our Biotech Department in the very early phases of the manufacturing process, and will allow us to offer a full service to clients wanting to enter quickly into the clinical phase”, commented Camilla Khevenhueller Borghese, President at IBI-Lorenzini.
Konstantin Matentzoglu, CEO at Celonic AG, added: “I am excited about this truly strategic partnership leveraging an innovative cell line development platform. Together, Celonic and IBI-Lorenzini will provide a safe and proven development platform to clients worldwide.”
IBI-Lorenzini is a privately owned pharmaceutical company, active in the market of injectable sterile beta-lactam antibiotics. A few years ago, it created a Biotech Department to enter the challenging world of biotechnological drugs. Their Biotech Department has the skills and capabilities to cover the whole process of manufacturing a biotech drug in CHO cells, starting from cell line engineering to GMP production of the drug for clinical testing. IBI-Lorenzini also has a dedicated Fill&Finish Department for the formulation and release of the Biotech Drug Products.
In 2015, the Italian Regulatory Agency (AIFA) authorized IBI-Lorenzini to conduct the GMP production of Biotech Drug Substances and Drug Products.
IBI-Lorenzini’s Biotech Department is actively working as a CDMO for the production of recombinant monoclonal antibodies and is also developing its own humanized monoclonal antibody in the oncology field.
Celonic AG is a privately owned CDMO based in Basel, Switzerland, providing comprehensive GMP development and manufacturing services for New Biological Entities (NBEs) and Biosimilars worldwide. Applying empathy, efficiency and excellence, Celonic goes one step beyond expectations in all business aspects in order to help its clients attain their goals more efficiently and reliably.
Celonic’s services include the development of cell lines, production processes, as well as the GMP and non-GMP manufacturing of biopharmaceutical drug substances. In addition, Celonic licenses its proprietary CHOvolution™ cell line technology to clients, drug developer and service provider.
IBI- Istituto Biochimico Italiano Giovanni Lorenzini Spa
Biotech Dept. Manager
Via Fossignano, 2- 04011 Aprilia (LT)
Eulerstrasse 55 - 4051 Basel
+41 61 56 49 171